OIG Assesses FDA Progress on Oversight/Inspections of Generic Drug Manufacturers

In a recent report, the HHS OIG concludes that FDA has made progress in improving oversight of generic drug manufacturers, including greater parity in inspections of foreign and domestic generic drug manufacturers. A summary of the report, FDA Has Made Progress on Oversight and Inspections of Manufacturers of Generic Drugs, is available on our Life Sciences Legal Update blog. 

House Approves "Ensuring Patient Access and Effective Drug Enforcement Act"

On April 21, 2015, the House of Representatives approved H.R. 471, the Ensuring Patient Access and Effective Drug Enforcement Act of 2015. The bipartisan legislation would clarify the Controlled Substances Act to establish consistent enforcement standards intended to protect against diversion while promoting patient access to medically-necessary controlled substances. 

GAO Calls for Expanded HHS Efforts to Reduce Antipsychotic Drug Use in Community Settings

The Government Accountability Office (GAO) has issued a report examining the extent to which antipsychotic drugs are prescribed for older adults with dementia in nursing homes and other settings. The GAO found that, according to Medicare Part D data, about one-third of older adults with dementia who spent more than 100 days in a nursing home in 2012 were prescribed an antipsychotic, compared to about 14% of Medicare Part D enrollees with dementia living outside of a nursing home were prescribed an antipsychotic that year. While several agencies within HHS have taken steps to address antipsychotic drug use in nursing homes as part of the National Alzheimer's Plan, these efforts have not applied to older adults in other settings, such as assisted living facilities or individuals' homes. The GAO therefore recommends that HHS update its National Alzheimer's Plan to expand outreach and educational efforts to reduce antipsychotic drug use among older adults with dementia residing outside of nursing homes; HHS concurred.  For details, see the full report, “Antipsychotic Drug Use: HHS Has Initiatives to Reduce Use among Older Adults in Nursing Homes, but Should Expand Efforts to Other Settings.” 

Energy & Commerce Committee Approves Bipartisan Public Health Bills

On February 11, 2015, the House Energy and Commerce Committee approved the following bipartisan public health bills:

  • H.R. 471, Ensuring Patient Access to Effective Drug Enforcement Act (to improve enforcement efforts regarding prescription drug diversion and abuse); 
  • H.R. 639, Improving Regulatory Transparency for New Medical Therapies Act, as amended (to amend the Controlled Substances Act to improve the efficiency, transparency, and consistency of the Drug Enforcement Agency’s process for scheduling new drugs); 
  • H.R. 647, Access to Life-Saving Trauma Care for All Americans Act (to reauthorize language from the Public Health Service Act to fund trauma care centers); and
  • H.R. 648, Trauma Systems and Regionalization of Emergency Care Reauthorization Act (to reauthorize grants supporting state and rural development of trauma systems and authorize new regionalized emergency care model pilot projects).

OIG Reviews Oversight of Compounded Pharmaceuticals Used in Hospitals

The OIG has issued another report examining the safety of compounded sterile preparations (CSPs) used in hospitals, in response to a 2012 meningitis outbreak caused by contaminated injections. This report, "Medicare’s Oversight of Compounded Pharmaceuticals Used in Hospitals," assesses the extent to which Medicare's oversight of hospitals addresses 55 practices for CSP oversight in acute-care hospitals recommended by various expert guidelines. While CMS and the four CMS-approved hospital accreditors addressed most of the recommended CSP-related practices at least some of the time, the OIG identified certain gaps, particularly with regard to review of hospital contracts with stand-alone compounding pharmacies. The OIG also questioned the human capital available by oversight entities to thoroughly review hospitals' preparation and use of CSPs, and the adequacy of surveyor training related to compounding. The OIG recommends that CMS: (1) ensure that hospital surveyors receive training on standards from nationally recognized organizations related to safe compounding practices; and (2) amend its interpretive guidelines to address hospitals' contracts with standalone compounding pharmacies. CMS concurred with the recommendations.

Congressional Panels Take Steps to Speed Patient Access to Medical Innovation

On January 27, 2015, the House Energy and Commerce Committee released its “21st Century Cures Act” discussion draft, the product of a year-long, bipartisan effort by the Committee to accelerate the pace of medical cures in the United States. The nearly 400-page bill addresses a wide range of topics, including, among many other things: the drug and device approval processes; clinical trials; Medicare coverage, payment, and coding; drug safety; and other proposals intended to streamline medical technology regulations across government. The Committee invites interested stakeholders to submit specific suggestions about how to improve the legislation; no deadline is specified.

In a related development, on January 29, the Senate Health, Education, Labor and Pensions (HELP) Committee launched its own initiative to examine and reform public policies in order to speed patient access to safe and effective medical products and treatments. To kick off this effort, the HELP Committee released a report entitled “Innovation for Healthier Americans: Identifying Opportunities for Meaningful Reform to Our Nation’s Medical Product Discovery and Development.” The report seeks feedback on a series of questions on ways to decrease the time and costs associated with bringing medical products to patients, including questions related to: more effectively targeting government resources; evaluating public-private partnerships; promoting biomedical research; streamlining clinical trial requirements; modernizing Food and Drug Administration medical product approval processes; and harmonizing US regulations with international standards. Feedback is requested by February 23, 2015. The Committee also intends to hold a series of hearings on issues raised in the report. 

Congressional Health Policy Hearings & Markups

On January 27, 2015, the House Energy and Commerce Subcommittee on Health held a hearing on bipartisan public health legislation, including:

  • Ensuring Patient Access to Effective Drug Enforcement Act (to improve enforcement efforts regarding prescription drug diversion and abuse);
  • Improving Regulatory Transparency for New Medical Therapies Act (to amend the Controlled Substances Act to improve the efficiency, transparency, and consistency of the Drug Enforcement Agency’s process for scheduling new drugs);
  • Veteran Emergency Medical Technician Support Act (to provide demonstration grants to states with a shortage of emergency medical technicians (EMTs) to streamline licensing requirements for military veteran EMTs);
  • Trauma Systems and Regionalization of Emergency Care Reauthorization Act (to reauthorize grants supporting state and rural development of trauma systems and authorize new regionalized emergency care model pilot projects); a bill to reauthorize language from the Public Health Service Act to fund trauma care centers; and
  • National All Schedules Prescription Electronic Reporting (NASPER) Reauthorization Act (to reauthorize programs to support state prescription drug monitoring programs).

On January 28, 2015, the Senate Finance Committee unanimously approved H.R. 22, the “Hire More Heroes Act," which is intended to allow businesses to hire veterans without them counting as a full-time employee under the Affordable Care Act (ACA) if the veteran already has medical coverage through the TRICARE program or the Veterans Administration. The House approved the legislation earlier this month.

Looking ahead, the following hearings are scheduled next week:

Electronic Distribution of Prescribing Information for Prescription Drugs & Biologicals

The FDA published a proposed rule on December 18, 2014 that would require electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or within the prescription drug or biological product packaging. FDA also is proposing that prescribing information intended for health care professionals will no longer be permitted to be distributed in paper form with the package from which a prescription drug or biological product is dispensed, except as provided by this regulation. According to the FDA, its proposal is intended to facilitate the distribution of updated prescribing information as new information becomes available or prescribing information changes are made, and to ensure that “the most current prescribing information for distributed prescription drugs will be available and readily accessible to health care professionals at the time of clinical decisionmaking and dispensing.” Comments on the proposed rule will be accepted until March 18, 2015.

NIH Releases Proposed Rule on FDAAA Requirements for ClinicalTrials.Gov Registration and Results Submission

NIH has just released a proposed rule that would clarify and expand requirements for the submission of clinical trial registration and results information, including adverse event information, to the ClinicalTrials.gov database in conformance with the Food and Drug Administration Amendments Act of 2007 (FDAAA). The rule would implement the statutory requirement for the submission of summary results information for trials involving drugs, biological products, and devices that are approved, licensed, or cleared by FDA, and it proposes to extend such requirements to clinical trials of drugs, biological products, and devices that are not approved, licensed, or cleared by FDA. Among other things, the proposed rule would require the responsible party (i.e., the trial sponsor or principal investigator) to register an applicable clinical trial no later than 21 days after enrolling the first participant, and results generally would be required to be submitted no later than 1 year after the completion date of the clinical trial (the date of final data collection for the primary outcome measure studied). Results submission could be delayed for up to two additional years with certification that either an unapproved, unlicensed, or uncleared product studied in the trial is still under development by the manufacturer or that approval will be sought for a new use of an approved, licensed, or cleared product that is being studied in the trial. Extension requests also could be submitted for “good cause.” With regard to adverse events reporting, the proposed rule would require the responsible party to submit information summarizing the number and frequency of adverse events experienced by participants enrolled in a clinical trial, by arm and organ system, and it specifies the form of that reporting. The proposed rule would require submitted information to be updated at least annually if there are changes to report, with provisions for more rapid updating in certain circumstances. The proposed rule does not impose requirements on the design or conduct of clinical trials or on the data that must be collected during clinical trials. The proposed rule is scheduled to be published on November 21, 2014, and comments will be accepted for 90 days after publication.

CMS Call: National Partnership to Improve Dementia Care in Nursing Homes (Dec. 9).

On December 9, 2014, CMS is hosting a call to provide an update on the CMS National Partnership to Improve Dementia Care in Nursing Homes. The partnership focuses on continuing to reduce the use of unnecessary antipsychotic medications and other potentially-harmful medications in nursing homes and eventually other care settings.

FDA Revises Guidance Defining Delays, Denials, Limits and Refusals of a Drug Inspection

This post was written by Vicki Morris.

The Food and Drug Administration (FDA) recently issued a notice announcing the Agency’s revised guidance for industry defining the types of action, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated. The revised guidance, entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection,” follows the enactment of the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), which added a provision (and teeth) to the Food, Drug, and Cosmetic Act (the FD&C Act) concerning inspections that render a drug “adulterated” – a new term used by the FDA in this context. Specifically, a drug adulterated under FDASIA “has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.” FDA issued the revised guidance in response to comments on the Agency’s draft guidance for industry of the same title issued in July 2013.

The revised guidance clarifies FDA’s expectations regarding the types of action, inaction, and circumstances that make a drug adulterated under FDASIA and the FD&C Act. FDA also provides examples that constitute reasonable explanations for actions, inactions, or circumstances that could otherwise be considered delaying, denying or limiting inspection, or refusing to permit entry or inspection, as discussed below.

Delays of Inspections: While the guidance acknowledges that delays may occur for many reasons – some of which are beyond the control of the facility – it explicitly states that where an owner, operator or agent causes the delay of an inspection, this may cause the drugs to be deemed adulterated. FDA provides examples of delaying a pre-announced inspection that include, but are not limited to:

  • A facility will not agree to a proposed inspection start date and does not give a reasonable explanation for its failure to do so
  • A facility, after scheduling an inspection, requests a later start date without giving a reasonable explanation
  • A facility fails to respond following the FDA’s attempt to contact the facility’s designated contact(s)

Delay During an Inspection: The guidance suggests that actions by a facility’s owner, operator, or agency before or after the beginning of an inspection, that impede an FDA investigator at the inspection site from performing the inspection in a reasonable manner, may be considered delaying the inspection. However, FDA notes that it will recognize minor delays from good faith efforts by the facility to comply with FDA requests as not unreasonable. FDA provides examples of delays during an inspection that may cause drugs to be adulterated:

  • A facility does not allow the FDA investigator access to an area of the facility until a specific future date or time, even though the area is operational and is an area of the inspection site that FDA has authority to inspect, without giving a reasonable explanation
  • A facility leaves the FDA investigator in a conference room without access to necessary documentation or responsible individual for an unreasonable period of time that interferes with the investigator’s ability to complete the inspection

Delays in Producing Records: FDA emphasizes the importance of the Agency’s preparation for inspecting drug facilities in collecting and reviewing hardcopy and electronic records, files and papers. The guidance offers examples of delays in producing records that may cause drugs to be deemed adulterated that include, but are not limited to:

  • The FDA investigator, during an inspection, requests, within a specific, reasonable timeframe, records that it has authority to inspect, but the facility fails to produce the requested records within the timeframe requested by the Agency, without reasonable explanation
  • The FDA requests records under its legal authority to do so, but the facility fails to produce the requested records in a timely manner, without reasonable explanation

FDA emphasizes that in instances where the facility provides a reasonable explanation for delaying production of records, the facility should also ensure that the resulting delay is of a reasonable duration.

Limiting of Inspection: The guidance explains four circumstances where an owner, operator, or agent of a drug facility prevents an authorized FDA representative from conducting an inspection that constitutes a limitation that may cause drugs to be deemed adulterated:

  • Limiting access to facilities and/or manufacturing processes
  • Limiting photography
  • Limiting access to or copying of records
  • Limiting or preventing collection of samples

While the guidance suggests that impeding or resisting photography by an FDA investigator may be considered a limitation if such photographs are determined by the investigator to be necessary to effectively conduct that particular inspection, there is no mention of the Agency’s authority to regulate this activity in MAPPs, FDA’s internal guidelines.

Refusal to Permit Entry or Denials of Inspection: FDA interprets the term “refuses to permit entry or inspection” to include not only active, but also passive behavior and non-action by the owner, operator or agent of a drug facility, to prevent an authorized representative of the FDA from conducting an inspection, or to prevent the FDA from completing an inspection. Denials of inspection also include statements or physical actions intended to avoid inspection, or to mislead, deceive or impede the investigator. FDA provides examples that may constitute denying an inspection that may cause drugs to be adulterated:

  • A facility ignores or rejects the FDA’s attempt to schedule a pre-announced inspection
  • The facility does not allow the FDA investigator, upon arrival at the facility, to enter the facility or begin the inspection
  • A facility does not allow the FDA investigator to inspect the facility because certain staff members are not present, without a reasonable explanation, or
  • A facility sends staff home for the day and tells the FDA investigator that the facility is not producing any product

Although neither the FDA’s revised guidance nor the FD&C Act specifically define “reasonable,” FDA has long maintained that the inspectional authority under section 704 of the Act “extends to what is reasonably necessary to achieve the objective of the inspection.” Further, FDA contends that it will consider reasonable explanations for behavior that may otherwise be considered to be delaying, denying, limiting, or refusing an inspection under the revised guidance. The guidance’s vagueness reinforces the importance of taking the following key steps to ensure FDA inspection compliance:

  • Review FDA rules and guidance on how to conduct a good inspection
  • Assess facility’s existing plans for FDA inspection
  • Develop written internal procedures and systems that specifically address inspectional issues
  • Consider rationale for any delays, limits, or denials of inspection
  • Train and prepare staff for FDA inspections, including understanding the company’s positions and employees’ roles before, during, and after FDA investigations
  • Track what is stored at the facility and what is provided to the authorized FDA representative at inspection

Vicki Morris (Law Clerk) is a member of the firm’s Life Sciences Health Industry Group and is based in our Washington, D.C. office.

DEA Issues Final Rule on Safe, Secure Disposal of Controlled Substances

The Drug Enforcement Administration (DEA) has published a final rule to implement the Secure and Responsible Drug Disposal Act of 2010, which was intended to mitigate prescription drug abuse by providing safe and secure mechanisms for “ultimate users” to dispose of unused or unwanted pharmaceutical controlled substances. The regulations allow authorized manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics with an on-site pharmacy, and retail pharmacies to voluntarily administer mail-back programs and maintain collection receptacles. In addition, this rule expands the authority of authorized hospitals/clinics and retail pharmacies to voluntarily maintain collection receptacles at long-term care facilities. According to the DEA, it has expanded the entities that may be authorized collectors in response to public concerns regarding ultimate users’ ability to have convenient disposal options. The rule also establishes standards related to each element of the disposal process, including the transfer, delivery, collection, destruction, return, and recall of pharmaceutical controlled substances. Also in response to comments, the DEA has relaxed some of the proposed security requirements related to storage and destruction of controlled substances. The rule is effective October 9, 2014. 

FDA Issues Draft Guidance on Communicating New Risk Information about an Approved Drug Product - Comment Opportunity

This post was written by Jillian W. Riley.

On June 6, 2014, the US Food and Drug Administration (FDA) issued a draft guidance addressing the distribution of new risk information to health care providers (HCPs) and health care entities (HCEs). The draft guidance defines “new risk information” as “information that becomes available after a drug is marketed that rebuts or mitigates information about a risk already identified in the approved labeling or otherwise refines risk information in the approved labeling in a way that does not indicate great seriousness of the risk.” The draft guidance is not intended to address risk information that is newly identified, but that which was not available at the time FDA approved the labeling. Acknowledging the evolving nature of a drug’s safety profile, the draft guidance is aimed at helping sponsors better communicate “new risk information” in order to allow HCPs and HCEs make the best decision for each patient.

Through the guidance, FDA lays out criteria for determining the appropriate circumstances under which to distribute “new risk information” to HCPs and HCEs. FDA does not intend to object to the distribution of new risk information as long as the distribution is consistent with the criteria established in the draft guidance.

The criteria are broken into two categories, those governing the data source and those governing the distribution. Both criteria categories must be met in order for a drug company to distribute new risk information that rebuts, mitigates, or refines risk information in the approved labeling.

Data source criteria include the following:

  • The study or analysis should meet accepted design and other methodologic standards and be sufficiently well-designed and informative;
  • If the data rebuts a prior determination about a causal connection between the drug and an adverse event, the study or analysis should be at least as persuasive as the data it is rebutting;
  • The conclusions should give appropriate weight and consideration to all relevant information in the safety database, including contrary or otherwise consistent findings; and
  • The study or analysis should be published in an independent, peer-reviewed journal.

Distribution criteria include the following:

  • The reprint or digital copy should be accompanied by a cover sheet that clearly and prominently discloses:
    • The study design, critical findings, and significant methodology
    • That the information is NOT consistent with certain risk information in the approved labeling
    • That FDA has not reviewed the data; and
    • Any financial interests or affiliations between the study author(s) and the drug company;
  • The reprint or digital copy should be accompanied by the approved product labeling;
  • The reprint or digital copy should be separate from any promotional material; and
  • Any statements made by a drug company representative to a HCP or HCE concerning the reprint should be consistent with the content and the disclosure information.

Comments on the draft guidance should be submitted by August 20, 2014.

FDA Initiative Opens Door to Easily Accessible, User-Friendly Data

This post was written by Jennifer Pike.

Yesterday, the U.S. Food and Drug Administration (FDA) made available data on millions of reports of drug adverse events and medication errors made to FDA between 2004 and 2013. The release of the data is part of FDA’s new data sharing initiative, openFDA, which is designed to make it easier for developers, researchers and the public to access data collected by FDA. OpenFDA organizes large amounts of publicly-available data in a structured, computer-readable format and makes it possible for users to instantaneously search and pull the data for their own use. . According to Walter Harris, FDA’s chief operating officer and acting chief information officer, “openFDA is a valuable resource that will help those in the private and public sectors use FDA public data to spur innovation, advance academic research, educate the public, and protect public health.”

For now, openFDA will begin as a pilot program with data involving the drug adverse event and medication error reports. FDA will later expand openFDA to include data on product recalls and product labeling.

OIG Examines Medicare Part B Payments for Compounded Drugs

The HHS OIG has examined Medicare Part B payments for compounded drugs and Medicare Administrative Contractors' (MAC) procedures for reviewing and processing claims for compounded drugs, in light of safety concerns involving a 2012 meningitis outbreak and increased scrutiny of compounded drugs. According to the OIG, neither CMS nor MACs tracked the number of Part B claims or payment amounts for compounded drugs, nor do Part B claims contain information that can be used to systematically identify claims for compounded drugs. The OIG observes that the current “inability to track claims for compounded drugs and identify the compounding pharmacies limits the ability of CMS and MACs to take steps that could stop payments for compounded drugs produced in violation of the [Federal Food, Drug, and Cosmetic] Act. The OIG therefore recommends that CMS (1) establish a method to identify Medicare Part B claims for compounded drugs, (2) explore the possibility of requiring providers to identify on Part B claims the pharmacy that produced the compounded drug, and (3) consider conducting descriptive analyses of Part B claims for compounded drugs.

CMS Call: National Partnership to Improve Dementia Care in Nursing Homes (May 20)

On May 20, 2014, CMS is hosting another call to discuss the National Partnership to Improve Dementia Care in Nursing Homes, which includes as a goal reducing the use of unnecessary antipsychotic medications in nursing homes. This call will focus on efforts to monitor enforcement rates and track surveyor training completion; the role that activity professionals play in the mission to improve dementia care; and nonpharmacologic care approaches.

Congressional Health Policy Hearings

 A number of Congressional committees have held hearings recently to address various health policy issues, including the following:

FDA to Overhaul an OTC System That "Isn't Working"

This post was written by Kevin M. Madagan and Jillian W. Riley

The Food and Drug Administration (FDA) has just announced that it will hold a public hearing March 25 and 26, 2014 to obtain input on the Agency’s current process for reviewing over-the-counter (OTC) drugs. This is a significant advancement in FDA’s long-standing plan to overhaul the OTC drug system. According to the announcement, the Agency’s OTC drug review “needs a critical examination at this juncture to examine whether and how to modernize its processes and regulatory framework.”

Teeing up the importance of the public hearing, Dr. Janet Woodcock, the Director of FDA’s Center for Drug Evaluation and Research (CDER), informed the Wall Street Journal that the Agency was “looking for creative ideas about how to improve the process.”1 According to Dr. Woodcock, “The current system isn’t working well for the public or for us.”  Additional details are available after the jump.


The FDA’s announcement highlights a number of challenges associated with the current OTC drug review process (sometimes referred to as the OTC Monograph Process, OTC Monograph, or OTC Drug Review), a process that has not changed in more than 40 years. FDA sees the biggest challenges as the following:

  • The large number of products currently on the market for which there are not yet final monographs. Much of the OTC marketplace is still not covered by final monographs, and data may be insufficient for FDA to determine safety and/or efficacy. An unintended consequence of the enforcement discretion given to products marketed in accordance with tentative final monographs (TFMs) is that it creates negative incentives for sponsors to conduct studies or otherwise respond to safety concerns, as to do so may slow the final monograph process.
  • The current system’s limitations on FDA’s ability to change the monograph to address new safety or efficacy issues. The current process is not sufficiently agile to adapt quickly to new safety concerns that arise either during the rulemaking process or after issuance of a final monograph.
  • The inability of the current OTC Drug Review to easily accommodate innovative changes to OTC products. According to the notice, the FDA generally thought at the time it established the OTC drug review process “that safety and effectiveness evaluations for the various active ingredients would be fairly straightforward and would not need continuous reexamination over time.” Yet, FDA has learned that this is not the case. Scientific advances have given rise to new information about how drugs interact with the body, changing how FDA evaluates drugs. This is particularly relevant in the context of pediatric OTC products, as the preferred approach to pediatric dosing has changed since the OTC drug review was instituted. The current OTC drug review process relies on extrapolated data from an adult population to determine pediatric dosing, however, as opposed to the currently accepted practice of relying on data from actual use in the pediatric population.


After discussing what it views as the current shortcomings with the system, the FDA asks for input as to how it can improve and modernize the OTC process. FDA is looking for changes to the existing framework or ideas for a complete replacement. The Agency presents some ideas as a starting point for discussion, as noted below. The FDA wants to hear all ideas – from detailed proposals to initial thoughts as to why the current process is not fully successful, noting that public comments “need not be comprehensive to be useful.”

The following are some of FDA’s preliminary proposals to modernize the OTC drug review program for which it seeks public input:

  • Identify a streamlined process that would allow a prompt resolution of existing tentative final monographs. FDA is considering ways to more efficiently bring TFMs to closure.
  • Issue monographs by administrative order. FDA is examining streamlining the monograph process to mimic the device reclassification process put in place by the Food and Drug Administration Safety and Innovation Act. Under this proposed process, monographs could be established by administrative order, after issuance of a proposed order for public comment.
  • Issue regulations to require product-specific information and expand the use of guidance. FDA is raising the possibility of new regulations that could require sponsors to submit limited information about individual products prior to marketing. This could be similar to, but less detailed than, a new drug application (NDA).
  • Expand the NDA deviation process. The OTC drug review process provides for an NDA deviation process. A sponsor applies for this deviation by showing that the product complies with all the conditions of a monograph except for the deviation, and provides FDA adequate data to demonstrate the safety and effectiveness of the product with the deviation. FDA questions why industry has not utilized this option and seeks input as to whether this process could be improved to increase utilization.


FDA will hold the public hearing March 25 and 26, 2014, at FDA’s White Oak Campus in Silver Spring, Maryland. The registration deadline is March 12, 2014, and FDA will be accepting comments until May 12, 2014.

1 http://online.wsj.com/news/articles/SB10001424052702304275304579395813156008466?mg=reno64-wsj&url=http%3A%2F%2Fonline.wsj.com%2Farticle%2FSB10001424052702304275304579395813156008466.html (this article requires a subscription).

CMS Call on Partnership to Improve Dementia Care in Nursing Homes (Feb. 26)

On February 26, 2014, CMS is hosting a call to discuss the National Partnership to Improve Dementia Care in Nursing Homes, which includes as a goal reducing the use of unnecessary antipsychotic medications in nursing homes. This call will focus on the role of surveyors in the implementation of the partnership, the importance of leadership, and the correlation between proper pain assessment and antipsychotic medication use.

Drug Distribution Security Legislation Signed into Law

This post was written by Kevin Madagan.

On November 27, 2013, President Obama signed into law H.R. 3204, the “Drug Quality and Security Act” (the “Act”), bipartisan drug distribution security legislation. Among other things, the sweeping measure: clarifies current federal law and regulatory oversight regarding pharmacy compounding; establishes a uniform, national drug tracking and tracing framework; mandates national licensure standards for wholesale distributors and third-party logistics providers; and preempts state product tracing requirements. The following is an overview of the Act and highlights of initial FDA implementation guidance.

Clarification of federal law and regulatory oversight regarding pharmacy compounding

The Act clarifies current federal law and regulatory oversight by distinguishing between traditional compounders and outsourcing facilities. It also requires enhanced communication between FDA and state regulators about compounding entities.

An outsourcing facility is a facility that compounds sterile drugs by or under the direct supervision of a licensed pharmacist, is registered with FDA as an outsourcing facility, and complies with all standards governing such facilities. Outsourcing facilities will need to comply with certain adverse event reporting requirements and report biannually (June/December) to FDA the drugs compounded during the previous 6-month period. FDA will subject outsourcing facilities to risk-based inspections. The benefit to registering as an outsourcing facility is that drugs compounded in such facilities will be exempt from new drug requirements, labeling requirements, and track and trace requirements. However, new labeling standards will apply to drugs compounded in outsourcing facilities. For instance, the label for a drug compounded in an outsourcing facility will need to contain the statements: “This is a compounded drug” (or a reasonable comparable alternative statement that prominently identifies the drug as a compounded drug) and “Not for resale.” The statement “Office Use Only” will be required on the labels of drugs that are dispensed or distributed other than pursuant to a prescription for an individual identified patient.

The Act requires enhanced communication between FDA and state regulators about compounding facilities. Specifically, state boards of pharmacy must submit information to FDA describing any “actions taken against compounding pharmacies” for issues pertaining to compounding, including, for example, “the issuance of a warning letter, or the issuance of sanctions or penalties, by a state for violating the state’s pharmacy regulations pertaining to compounding.” State boards of pharmacy must also submit any information “expressing concerns” that a compounding pharmacy “may be” acting contrary to federal pharmacy compounding laws. The federal government must consult with the National Association of Boards of Pharmacy before implementing these mandatory reporting standards, and then must “immediately” notify “state boards of pharmacy” when it receives one of these mandatory reports or when it determines that a pharmacy is acting contrary to federal pharmacy compounding laws.

FDA recently issued numerous statements and draft guidance documents about how it interprets and intends to implement these and other requirements of the Act.

Uniform, national drug tracking and tracing framework

The Act establishes a uniform, national drug tracking and tracing framework to track prescription drugs from the manufacturer to the pharmacy. It does this by requiring manufacturers to serialize prescription drugs at the unit level. The Act then establishes unit-level product tracing requirements for “downstream” pharmaceutical supply chain members (drug manufacturers, repackagers, wholesale distributors, and dispensers).

National licensure standards for wholesale distributors

Beginning January 1, 2015, the Act requires any person who owns or operates an establishment that engages in wholesale distribution to report the following information to the Secretary on an annual basis: (1) each state by which the person is licensed and the appropriate identification number of each such license; (2) the name, address, and contact information of each facility at which, and all trade names under which, the person conducts business. Wholesale distributors must also report to the Secretary “within a reasonable period of time and in a reasonable manner” (as determined by the Secretary) any “significant disciplinary actions, such as the revocation or suspension of a wholesale distributor license,” taken by a state or the federal government.

For the purpose of ensuring uniformity with respect to wholesale distribution standards, the Act requires the Secretary to establish additional wholesale distribution standards governing: (1) the storage and handling of prescription drugs, including facility requirements; (2) the establishment and maintenance of records of the distribution of such drugs; (3) the furnishing of a bond or other equivalent means of security; (4) mandatory background checks and fingerprinting of facility managers or designated representatives; (5) the establishment and implementation of qualifications for key personnel; (6) the mandatory physical inspection of any facility to be used in wholesale distribution; and (7) the prohibition of certain persons from receiving or maintaining licensure for wholesale distribution (e.g., persons convicted of a felony for conduct relating to wholesale distribution). In addition, if a state chooses not to establish a licensing program for a wholesale distributor, the federal government must license the distributor and collect reasonable fees to cover the costs of administering a federal licensing program for entities in such states.

National licensure standards for third-party logistics providers

Beginning one year after the date of enactment of the Act, a facility of a third-party logistics provider must report to the federal government on an annual basis: (1) the state by which the facility is licensed and the appropriate identification number of such license; and (2) the name and address of the facility and all trade names under which such facility conducts business. If a state chooses not to establish a licensing program for a third-party logistics provider, the federal government must license the provider and collect reasonable fees to cover the costs of administering a federal licensing program for entities in such states. The Act also allows for a third-party accreditation program to be developed to license providers and requires the federal government to issue regulations regarding the standards for licensing third-party logistics providers. Third-party logistics providers will be subject to periodic inspection by their licensing authority and must provide the applicable licensing authority, upon a request by such authority, a list of all product manufacturers, wholesale distributors, and dispensers for whom the third-party logistics provider provides services.

Preemption of state product tracing requirements

The product tracing requirements set forth in the Act preempt state product tracing requirements, including paper or electronic pedigree systems. Preemption resolves a long-standing problem facing the drug distributor industry: the increasingly complex, and often conflicting, state pedigree requirements, many of which are not fully established or have staggered implementation deadlines.

Older Entries

November 25, 2013 — Congressional Panels Continue Focus on ACA Insurance Enrollment, Security, and Cost Issues, and Other Health Policy Topics

September 17, 2013 — HHS Seeks Comments on Draft National Action Plan for Adverse Drug Event Prevention

August 2, 2013 — FDA Proposes New Rule to Exercise its Administrative Detention Authority for Drugs

August 2, 2013 — New Draft Guidances from FDA Address Expedited Review, Safety Labeling and More

June 27, 2013 — OIG Focuses on Inappropriate Prescribing of Medicare Part D Drugs

June 27, 2013 — Health Policy Hearings

June 25, 2013 — CMS Call on Improving Dementia Care in Nursing Homes (July 10)

June 11, 2013 — Health Policy Hearings

June 5, 2013 — House Approves Drug Distribution Security Plan

May 28, 2013 — OIG Report Examines High-Risk Compounded Sterile Preparations

April 24, 2013 — Lawmakers Float Draft Drug Distribution Security Plan; Comment Opportunity

January 11, 2013 — FDA Draft Guidance Addresses Clinical Trial Enrichment

January 11, 2013 — FDA Issues Two Final Guidances on Safety Reporting Requirements

November 28, 2012 — Upcoming FDA Public Meeting: Framework for Pharmacy Compounding/State and Federal Roles (Dec. 19)

November 12, 2012 — November Congressional Health Policy Hearings

October 15, 2012 — Short-Term Government Funding, FDA User Fee & Safe Doses Bills Signed into Law

September 27, 2012 — Senate Approves Legislation to Combat Medical Product Theft

July 31, 2012 — Congressional Health Policy Hearings

June 28, 2012 — Congress Clears FDA Safety & Innovation Act

June 27, 2012 — Health IT Pilot Targets Prescription Drug Abuse

June 27, 2012 — CMS Outlines Conditions for Provider Use of Repackaged Medications

June 27, 2012 — House Approves Medical Product Counterfeiting Act

June 18, 2012 — House Panel Clears Legislation to Address Medical Product Theft, Counterfeiting

May 31, 2012 — House, Senate Approve FDA User Fee/Drug Safety Bills

May 11, 2012 — House Panel Unanimously Approves FDA User Fee Act

May 11, 2012 — FDA Reports on Post-Approval Drug Safety Monitoring

March 29, 2012 — FDA Draft Guidance on Classifying Significant Postmarket Drug Safety Issues

March 29, 2012 — FDA Issues Guidance Update on Communication to the Public about Drug Safety

March 14, 2012 — Senate Approves Bill to Increase Counterfeit Drug Penalties

March 14, 2012 — Congressional Hearings on Drug Issues.

February 24, 2012 — Congressional Health Policy Hearings & Markups

January 25, 2012 — GAO Examines Prescription Pain Reliever Abuse

December 29, 2011 — FDA Guidance Regarding Responding to Unsolicited Requests for Off-Label Information

December 13, 2011 — Counterfeit Drug Penalties

November 10, 2011 — FDA Announces Review of Bar Code Final Rule

November 10, 2011 — President Issues Executive Order Regarding Drug Shortages

October 14, 2011 — FDA Issues Final Guidance on Risk Labeling for Prescription Drugs and Biological Products

September 29, 2011 — GAO Assesses DEA Prescription Drug Control Efforts

September 29, 2011 — Congressional Hearings Examine Variety of Health Industry Issues

September 26, 2011 — FDA Guidance on Reproductive and Developmental Toxicities

September 22, 2011 — Upcoming House Hearings on Drug Shortages, Device/Drug Regulations

September 8, 2011 — Upcoming Congressional Hearings on Health Care Industry Consolidation, Pharmaceutical Supply Chain Security

June 28, 2011 — FDA Proposed Rule to Amend Sterility Test Requirements for Biologicals

June 14, 2011 — GAO Report on FDA Tracking of Pediatric Research

May 13, 2011 — FDA Reestablishes Medical Imaging Drugs Advisory Committee

April 12, 2011 — Congressional Hearings This Week on FDA Medical Device Approvals, Drug Imports/Diversion

March 7, 2011 — FDA Draft Guidance Documents: Electronic Data Sets for Pharmacoepidemiologic Studies, Pharmacogenomics/Premarketing Evaluation, REMS Medication Guides

January 13, 2011 — FDA Meeting on Tracing and Tracking Prescription Drugs (Feb. 15-16)

October 28, 2010 — GAO Issues Two Reports Examining FDA Foreign Inspection Issues

October 15, 2010 — FDA Enters Agreement to Support WHO with Counterfeit Drug Efforts

September 30, 2010 — FDA Issues Final Rule, Draft Guidance on Clinical Trial Safety Reporting Requirements

September 28, 2010 — House E&C Committee Plans Hearing on Drug Safety Bill (Sept. 30)

July 29, 2010 — House Committee Approves Health Legislation

July 29, 2010 — Congressional Health Policy Hearings

July 7, 2010 — FDA Seeks Comments on Draft Guidance on Changes to CMC Reportable Information

June 18, 2010 — Congressional Hearings on Health Care Fraud, Health Policy Issues

June 18, 2010 — FDA Meeting on Risk Evaluation and Mitigation Strategies (July 27-28)

June 18, 2010 — FDA to Post New On-line Information Regarding Safety Monitoring Issues for Recently-Approved Drugs and Biologics

June 8, 2010 — Upcoming Hearing on Antibiotic Development and Use

May 28, 2010 — Congressional Hearings

May 27, 2010 — DOJ Health Fraud Activities, Focus on Pharmaceutical Companies

May 25, 2010 — FDA and NIH Launch Safety Reporting Website

May 13, 2010 — FDA Experimental Study of Patient Information Prototypes

April 29, 2010 — April 2010 Congressional Hearings

March 31, 2010 — FDA Issues Proposed Rule on Clear and Conspicuous Standard for DTC Advertisements

March 31, 2010 — FDA Issues Guidance Document on Drug Pedigree Issues

March 31, 2010 — FDA Guidance on Content and Format of the Dosage and Administration Section of Labeling

March 15, 2010 — Congressional Hearings

March 8, 2010 — House Energy & Commerce Drug Safety Hearing Set for March 10

February 26, 2010 — FDA Listing of Drugs with Potential Safety Issues

February 12, 2010 — Draft Guidance on Assessment of Abuse Potential of Drugs

February 12, 2010 — Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

February 12, 2010 — Guidance on Complete Submissions for the Evaluation of Proprietary Names

December 21, 2009 — GAO Report on Drug Safety Oversight

December 4, 2009 — FDA Announces Safe Use Initiative for Drug Products

December 4, 2009 — FDA Issues Warning Letters to Web Site Operators

December 4, 2009 — FDA Guidance Documents

November 11, 2009 — Renal Dialysis Facility ESA Policies

October 30, 2009 — Drugs Approved on the Basis of Surrogate Endpoints

October 30, 2009 — Off-Label Cancer Therapies

October 15, 2009 — FDA Postmarketing Safety Reporting for Combination Products

October 15, 2009 — FDA Strategic Plan for Risk Communication

October 15, 2009 — FDA Guidance Documents

September 28, 2009 — Congressional Hearings

September 4, 2009 — FDA Proposed Rules on Electronic Reporting of Adverse Drug and Device Events

July 28, 2009 — FDA Workshop on Prescription Drug Risk Information

July 7, 2009 — AHRQ Off-Label Drug Use Report

June 8, 2009 — Toll-Free Numbers for Adverse Events Reporting

June 8, 2009 — FDA Sentinel System/Privacy & Security Issues

May 7, 2009 — Label Comprehension Studies for Nonprescription Drugs

April 23, 2009 — Summary Bioequivalence Data for Abbreviated New Drug Applications (ANDA)

April 23, 2009 — Summaries of Effectiveness and Safety

April 6, 2009 — FDA Meeting, Comment-Period on Economically Motivated Adulteration

February 11, 2009 — FDA Listing of Drugs with Potential Safety Issues

January 27, 2009 — High-Risk Programs (Medicare, Medicaid, FDA)

January 27, 2009 — Good Reprint Practices

January 27, 2009 — Secure Supply Chain Pilot Program

January 27, 2009 — Good Importer Practices Draft Guidance

January 27, 2009 — Standardized Numerical Identification for Prescription Drug Packages

January 27, 2009 — Submission of Laboratory Packages by Accredited Laboratories