FDA Meeting on Biomarker Development (Sept. 5)

On September 5, 2014, the FDA is holding a public meeting at the Washington Plaza Hotel, in Washington DC, to discuss current scientific and regulatory approaches to biomarker development, acceptance, and utility in the development of therapeutic products (e.g., drugs and biologics). Specifically, FDA will focus on (1) identifying challenges for biomarker applications in early- and late- phase clinical trials, and (2) emerging best practices for successful biomarker-based programs (including codevelopment of in vitro diagnostic devices and use of biomarkers as outcome measures in clinical trials). Public input from the meeting will be used to identify opportunities for biomarker-related regulatory guidance, improve understanding and consistency in regulatory review of therapeutic product applications that incorporate biomarkers in clinical trial designs, and identify potential strategies to facilitate scientific exchanges in regulatory and non-regulatory contexts. For more information on the meeting, which is being held in collaboration with Brookings Institution, and for early registration deadlines to attend the live meeting, see the FDA announcement.  FDA will also accept comments on this topic through November 5, 2014.

FDA Will Not Enforce Compliance for Mobile Device Data Systems and Other Low Risk Devices, Agency Reports

This post was written by Jennifer Pike.

In a new draft guidance document, the Food and Drug Administration (FDA) has announced that it does not intend to enforce compliance with general regulatory controls that apply to Medical Device Data Systems (MDDS), medical image storage devices and medical image communications devices.

MDDS refers to hardware and software that transfers, stores, converts format and displays medical device data, but that does not modify the data or control the functions or parameters of any connected medical device. In 2011, MDDS were classified by FDA as Class I medical devices subject to general regulatory controls under the Federal Food, Drug and Cosmetic Act. FDA has since determined that MDDS pose a low risk to the public and play an important role in advancing health.  The agency has therefore decided not to enforce compliance with the controls that apply to MDDS, medical image storage devices and medical image communications devices (e.g., registration and listing, premarket review, postmarket reporting and quality system regulation).

The draft guidance also proposes changes to FDA’s draft guidance titled “Mobile Medical Applications” issued on September 25, 2013 to conform with the new draft guidance.

Comments regarding the draft guidance should be submitted to FDA by August 25, 2014.

FDA Releases Drug/Device Industry Social Media Guidance Documents

The FDA released two draft social media guidance documents last week, describing how manufacturers, packers and distributors of prescription drugs and medical devices may: (1) communicate both benefit and risk information on Internet/social media platforms with character space limitations, and (2) correct independent third-party misinformation about a firm’s products.  For details, see Reed Smith's Client Alert posted on our Life Sciences Legal Update blog.

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.

Expedited Drug Development and Review: New FDA Resource Now Available

This post was written by Jennifer Pike.

A new guidance entitled “Expedited Programs for Serious Conditions – Drugs and Biologics” is now available from the Food and Drug Administration (FDA). The 40-page guidance is intended to serve as a single resource for information on FDA’s policies and procedures related to its four expedited drug development and review programs: (1) fast track designation, (2) breakthrough therapy designation, (3) accelerated approval, and (4) priority review designation. The guidance also defines the threshold criteria generally applicable to each program, including when a condition is considered “serious,” when a therapy is “available therapy,” and when a medical need is “unmet.”   The guidance follows the 2012 passage of the Food and Drug Administration Safety and Innovation Act, which called for FDA to expand its efforts to expedite the development and review of drugs intended to treat serious conditions.  Comments regarding the guidance may be submitted at any time.

FDA Workshop to Focus on 3-D Printing of Medical Devices

According to the Food and Drug Administration (FDA), additive manufacturing, also known as 3-D printing, is entering mainstream use in medical devices, both as an alternative device production method for traditional components and as a method to create patient-matched devices. FDA has begun to receive submissions using additive manufacturing for medical devices, and the agency sees “many more on the horizon.” As the use of additive manufacturing becomes more widespread, the FDA wants additional information on scientific and technical challenges associated with the use of such technology for medical devices, particularly with regard to process verification and validation to ensure patient safety. To that end, the FDA is hosting a public workshop on October 8 and 9, 2014 entitled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3-D Printing.'' The meeting is intended to provide a forum for FDA, medical device manufactures, additive manufacturing companies, and academia to explore this issue in detail, including ways to provide a transparent evaluation process for future submissions. The workshop discussion may facilitate development of new draft guidances and/or standards for additive manufacturing of medical devices. Comments on the workshop topic will be accepted until November 10, 2014.

Hundreds of Drugs and Biologics Face Labeling Changes under New FDA Plan

This post was written by Jennifer Pike.

In a notice published in the Federal Register on May 7, 2014, the U.S. Food and Drug Administration (“FDA”) announced its intent to incentivize manufacturers to voluntarily update their prescription drug and biologics labels by using a government contractor.

FDA’s announcement stems from a January 2006 final rule in which FDA established revised content and format requirements for prescription drugs and biologics (the “Physician Labeling Rule” or “PLR”). The PLR required drugs and biologics approved after June 30, 2001 to adopt the new labels. A detailed implementation schedule under the PLR, which only resulted in only 15% of all drug and biologics being labeled in the PLR format, expired in November 2013. Therefore, moving forward, the only products which will be labeled in the PLR format will be new drugs and biologics and drugs that are voluntarily updated. To address this lack of labeling conversion, on February 6, 2013, FDA proposed the Prescription Drug Labeling Improvement and Enhancement Initiative. As part of the initiative, and as explained in detail in FDA’s notice, FDA plans to use a government contractor to provide PLR conversion resources and services, including preparation of draft PLR format labeling, in hopes of facilitating voluntary conversion.

The number of drugs and biologics affected by FDA’s initiative is staggering. FDA estimates that 375 manufacturers will be contacted over a 5 year period regarding 750 products. FDA will select the products for labeling conversion based on criteria that would maximize the benefit to public health, including volume of prescriptions, clinical relevance, and risk-based  considerations. Beyond the 750 products selected for PLR conversion, FDA further estimates that over 1,800 generic products will require labeling updates to reflect changes made to the corresponding brand-name products.

FDA is seeking public comment on its collection of information related to the initiative. Comments should be submitted in writing, or electronically at www.regulations.gov, on or before July 7, 2014.

Busy Week for FDA's Center for Devices and Radiological Health

This post was written by Jillian W. Riley

Earlier this week, FDA’s Center for Devices and Radiological Health (CDRH) published two separate draft guidance documents to advance the dual goals of FDA and industry to provide pathways for medical devices to reach the market quickly while ensuring the safety and efficacy of the product.

The first guidance, entitled Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval, clarifies FDA’s current thinking on creating an effective means to achieve “the right balance of premarket and postmarket data collection facilitates timely access to important new technology without undermining patient safety.” Greater reliance on postmarket data collection can help a new product reach the market – and patients – sooner. One key factor FDA considers when determining whether postmarket data collection is appropriate is the device’s potential impact on public health. For example, and as discussed more thoroughly in the separate guidance discussed below, FDA may accept greater pre-approval uncertainty regarding specific benefits and risks of devices where there is demonstrated potential to address unmet medical needs.

The second guidance, Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions, proposes a new expedited review program for medical devices that address unmet medical needs and are subject to premarket approval (PMA) applications. The program laid out in the draft guidance establishes opportunities for earlier and more active engagement between sponsors and FDA staff, including earlier involvement of senior management to ensure more consistency in messaging to industry. The early interactions aim to establish better plans for efficient collection of the scientific and clinical data necessary to support FDA’s approval determinations. The guidance also describes the criteria an applicant must meet in order to obtain an expedited access PMA designation.

FDA will be accepting comments regarding the draft guidances until July 23, 2014.

Will Physician Payment Sunshine Act Data Usher in a New Era of False Claims Act Litigation?

This post was authored by Scot Hasselman, Elizabeth Carder-Thompson, Katie Pawlitz and Jillian Riley.

While attention has been focused on Medicare physician payment data released by CMS yesterday, upcoming Sunshine Act data will shine a new spotlight on financial relationships between physicians and pharmaceutical and medical device companies – with potential FCA implications.

Last week marked the deadline for pharmaceutical and medical device manufacturers and group purchasing organizations (GPOs) to register with and submit aggregate 2013 payment and investment interest data to the Centers for Medicare & Medicaid Services (CMS) on certain financial relationships between themselves and physicians and teaching hospitals, as required by the Physician Payment Sunshine Act.1 In May, manufacturers and GPOs will be required to submit to CMS detailed 2013 payment data. With some exceptions, CMS will be making these data public by September 1, 2014. While the publicly available data are intended to provide more transparency for patients – to allow them to have a better understanding of the financial relationships between physicians and pharmaceutical and medical device companies – patients will certainly not be the only group interested in this public information. The Department of Health and Human Services (HHS) Office of the Inspector General (OIG), Department of Justice (DOJ), and relators’ attorneys will likely utilize these data to initiate investigations and support complaints under the federal False Claims Act (FCA). As with the recent release of the 2012 Medicare Part B Physician Fee Schedule data, members of the media will likely make inferences about certain financial relationships.

The U.S. government recovered $3.8 billion in settlements and judgments from civil cases involving fraud against the government in the fiscal year ending Sept. 30, 2013.2 Fiscal 2014 looks to be a record-breaking year, with ever-increasing civil settlements by major pharmaceutical companies.3

As the reporting deadlines approach, it is worth considering an interesting, and largely unknown, potential implication of the public availability of these data: How will it affect future FCA litigation? The publically available Sunshine Act data could become relevant to FCA litigation in a variety of ways; two in particular are discussed below.

Anti-Kickback Statute Violations

The data could give rise to suspicions of violations of the federal Anti-kickback Statute (AKS). The AKS makes it a criminal offense to knowingly and willfully offer or pay remuneration to induce the referral of, or arrange for the provisions of, federal health care program business.4 In other words, the law prohibits any person or entity from giving, receiving – or offering to give or receive – anything of value in return for or to induce referrals for businesses covered by Medicare, Medicaid, or any other federally funded health care program. Violators of the AKS face imprisonment, criminal, and civil fines, as well as exclusion from federal health care programs.5

It is easy to see how publishing information regarding payments from pharmaceutical and medical device manufacturers to physicians and teaching hospitals could implicate the AKS, and by extension, the FCA. The Patient Protection and Affordable Care Act (ACA) made explicit that violations of the AKS are also violations of the FCA.6 Any payment from a pharmaceutical or medical device manufacturer to a physician who prescribes a product manufactured by the company providing the payment could be viewed as potentially inappropriate remuneration intended to influence prescribing behavior.

Off-Label Promotion

Publically available information reported as a result of the Sunshine Act may also have off-label promotion implications. Notably, reports to CMS must include the name of the drug or the type of device that forms the basis of the payment.7 Tying the payment to a particular drug or type of device could raise suspicions of off-label promotion. A pharmaceutical or medical device manufacturer that promotes its products for uses for which the product has not yet been approved by the United States Food and Drug Administration (FDA), i.e., off-label uses, is at risk of FCA liability. A false claim can arise when a manufacturer promotes a product for off-label, non-covered uses (that is, for a use that both has not been approved by FDA and is not covered by the federal health care programs). Payments going to physicians who specialize in an area that is outside the scope of a pharmaceutical or medical device’s approved indication could necessarily raise suspicions that the manufacturer is promoting the product for unapproved uses.

Potential Limits

Besides the risk of government identifying potential issues for further investigation and prosecution as a result of reported Sunshine Act data, private parties may also mine the publically available data. One substantial impediment to relators’ attorneys using Physician Sunshine Payment data in FCA litigation is the limitation that publicly available data cannot form the basis of a whistleblower claim.8 This is known as the public disclosure bar, although the effectiveness of this defense has been diminished with recent FCA amendments.

That said, the Sunshine Act data, even if not the basis of a claim, could nonetheless impact the litigation in many ways. For example, it could provide additional evidence for the government to review in reaching its decision whether to intervene in a qui tam action. Both OIG and DOJ could review the data before it is publicly available to assist in the determination that a given matter warrants intervention. Additionally, the publicly available data – beyond providing flavor in support of an FCA claim and assisting with meeting the heightened pleading standard associated with fraud allegations9 – could be a potential mine for plaintiff attorneys to locate areas of focus. Relators’ attorneys will no doubt track the data to ascertain potential problem drugs or companies about which they can then dedicate efforts to uncovering fraud and abuse in the federal health care system.

Going Forward

It remains to be seen how all of these risks will play out going forward. Courts will have to decide how these new data will fit into FCA litigation. OIG and DOJ will have to determine how much to rely on the new information. And relators’ attorneys will need to make decisions about how many resources to dedicate to mining the Sunshine Act data.

One potential consequence that we are already starting to see occur is that pharmaceutical and medical device manufacturers may halt or limit payments to physicians, and/or that physicians themselves will be reluctant to accept such payments, e.g., for research, for expenses associated with training on a device, and the like. Companies may decide to do so for a variety of reasons, including avoiding the administrative burdens associated with tracking and reporting such payments for purposes of the Sunshine Act, fear of FCA litigation, or for public relations reasons. Many physicians simply do not want their names publicized. It remains to be seen how these trends will evolve.
 

1 42 C.F.R. § 403.908(a).
2 DOJ Press Release, available at: http://www.justice.gov/opa/pr/2013/December/13-civ-1352.html. 3 See, e.g., DOJ Press Release, available at: http://www.justice.gov/opa/pr/2013/November/13-ag-1170.html.
4 42 U.S.C. § 1320a-7.
5 Id.
6 42 U.S.C. § 1320a-7b(g). Note that manufacturers may submit “assumptions documents” as part of Sunshine reporting. Although CMS stated in the preamble to the Sunshine regulations its belief that the contents of such documents “should not be made public,” it acknowledged that it could provide access to the documents during an audit or investigation by other HHS divisions, the Office of Inspector General, or the Department of Justice.
7 42 C.F.R. 403.94(c)(8).
8 31 U.S.C. § 3730(e)(4).
9 Fed. R. Civ. P. Rule 9(b).

April Congressional Hearings

Recent Congressional hearings on health policy issues include the following:

  • House Energy and Commerce Committee hearings on the “Helping Families in Mental Health Crisis Act”; the FDA’s proposed changes to generic drug labeling; and legislation intended to improve predictability and transparency in Drug Enforcement Agency and FDA regulation (H.R. 4299, H.R. 4069, and H.R. 4250).
  • House Ways and Means Health Subcommittee hearing on final Treasury Department regulations implementing the employer mandate and employer information reporting requirement provisions of the ACA..

In addition, on April 9, 2014, the Senate Health, Education, Labor and Pensions Committee is holding a hearing on “Addressing Primary Care Access and Workforce Challenges: Voices from the Field.”

FDA Proposal Amends Medical Device Classification Rules

This post was written by Jennifer Pike.

On March 25, 2014, the Food and Drug Administration (FDA) published a proposal to amend its regulations governing the classification and reclassification of medical devices. In addition to conforming the regulations to recent changes made by the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), the proposed rule makes changes unrelated to FDASIA. Among other changes to 21 CFR Part 860, FDA proposes to:

  • Amend several definitions at 21 CFR § 860.3, including the definitions of Class I, Class II and Class III to reflect the key principle underlying device classification that a reasonable assurance of safety and effectiveness is necessary for all three classes, but that the level of regulation necessary to provide such assurance is specific to the level of risk.
  • Amend the definition of Class III to clarify which devices fall in this category.
  • Establish special controls for Class II devices by replacing the term “performance standards” in 21 CFR § 860.7.
  • Amend 21 CFR § 860.84 to remove from the classification process the requirement to answer the classification questionnaire and provide information using the supplemental data sheet.
  • Revise the procedure at 21 CFR § 860.130 to reflect the FDASIA requirement that devices reclassified under 513(e) of the Food, Drug and Cosmetic Act be reclassified using an administrative order procedure.
  • Revise the process under 21 CFR § 860.133 for the filing of a premarket approval for Class III preamendment devices to conform to FDASIA.

Comments to the proposed rule may be submitted in writing, or at www.regulations.gov, on or before June 23, 2014.

March Congressional Health Policy Hearings

Congressional panels continue to hold hearings to address various health policy issues, including the following:

Drug Companies are Reminded - FDA is Following Facebook

Our Life Sciences Legal Update blog reports today that the FDA’s Office of Prescription Drug Promotion has warned a Swiss drug company about statements the company made on its Facebook page, suggesting that consumers talk to their doctor about a drug without disclosing the risks associated with the product (risks serious enough to require a boxed warning on the label). The FDA action is a reminder that that FDA’s advertising and promotion rules apply regardless of how or where the product is promoted, and the FDA is monitoring social media sites for such activities. For more information, see the full post.

There are HOW many calories in that? FDA Seeks Comments on Proposal to Update Nutrition Facts Food Label

As mentioned on our Life Sciences Legal Update blog, the Food and Drug Administration (FDA) announced today it has proposed significant updates to the Nutrition Facts label for foods intended to expand and highlight the information consumers need to make well-informed food choices.  FDA also is proposing changes to how serving sizes themselves are calculated. FDA will be accepting comments on the proposed regulations for 90 days.  To read the entire post, click here.

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 CURRENT SYSTEM

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.

THE PROPOSED OVERHAULS

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.

HEARING DETAILS

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).

Coming to a TV Near You? FDA Seeks Public Input on Limiting Risks Presented in Direct-to-Consumer Television Ads

This post was written by Jennifer Pike.

In a notice published in the Federal Register on February 18, 2014, the Food and Drug Administration (FDA) asked for feedback on a proposed research study related to prescription drug television advertisements. The study, Disclosure Regarding Additional Risks in Direct-to-Consumer (DTC) Prescription Drug Television (TV) Advertisements (Ads), would investigate the impact of limiting the risks presented in DTC prescription drug TV ads to those that are serious and actionable. The ads would also include a disclosure statement to alert consumers that there are other product risks not included in the ad.

Current FDA regulations (21 CFR § 202.1) require that TV and radio ads present a product’s major risks in audio, or audio and visual parts of the ads (“major statements”). FDA is concerned that these major statements are too long, resulting in reduced consumer comprehension, minimization of important risk information, and potentially, therapeutic noncompliance due to fear of side effects. At the same time, and in conflict with the above, FDA is concerned that DTC TV ads do not include adequate risk information. FDA believes that providing limited risk information in ads will promote improved consumer perception and understanding of serious and actionable drug risks.  Comments to the study should be submitted in writing, or electronically at www.regulations.gov, by April 21, 2014.

FDA Provides Direction on "Dear Doctor" Letters

This post was written by Jillian W. Riley.

On January 16, 2014, the Food and Drug Administration (FDA) issued a final guidance document for industry providing specific recommendations on the content and format of Dear Health Care Provider (DHCP or “Dear Doctor”) letters. DHCP letters are an important means of communicating new information to the health care provider community about a product that is already on the market. The guidance provides insight into (1) when to send a DHCP letter, (2) what information should be included, (3) how to organize the letter, and (4) how to format the letter. The recent guidance finalizes a draft guidance FDA published in November of 2010. 

The guidance stresses the importance of collaborating with FDA when crafting DHCP letters to ensure that a DHCP letter is appropriate under the circumstances, that the target audience has been identified, and that the message is clearly conveyed. Additionally, the guidance provides template examples to aid industry in drafting a clear and effective DHCP letter.

FDA Seeks Comments on Drug Company Social Media Guidance

As reported on our Life Sciences Legal Update blog, the FDA has issued draft guidance addressing the unique challenges of drug promotion in the age of social media. Specifically, the draft guidance addresses how to submit interactive promotional media for postmarket review.  Comments on the document, “Draft Guidance for Industry on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics,” are due April 14, 2014.

CMS, FDA Extend Pilot Program for Parallel Review of Medical Products

In October 2011, CMS and the FDA formally launched a voluntary parallel review pilot program for sponsors of medical devices. At the time, the agencies stated that they intended to run the pilot program for two years, with the possibility of an extension. In a December 18, 2013 notice, the FDA and CMS announced that they were extending the program for another two years in light of the significant interest in the pilot. The agencies are working through the process with the approved pilot program participants, and they will formally evaluate the program after a “representative group of participants have completed the pilot process.”

Older Entries

January 7, 2014 — FDA Releases Final Guidance on Qualification Process for Drug Development Tools

December 10, 2013 — Drug Distribution Security Legislation Signed into Law

November 14, 2013 — Congressional Hearings Focus on HealthCare.gov Enrollment, Other Policy Issues

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 20, 2013 — Draft FDA Guidance Recommends Cybersecurity Risk Assessments and Management Plans for Premarket Medical Device Submissions

June 20, 2013 — FDA Amends Orphan Drug Regulations

June 5, 2013 — House Approves Drug Distribution Security Plan

May 28, 2013 — FDA Issues New Draft Guidance Documents on Access to Investigational Drugs

April 15, 2013 — April Congressional Health Policy Hearings & Markups

April 15, 2013 — FDA Draft Guidance on Biosimilar Product Development Now Available

March 12, 2013 — FDA Issues New Guidance Documents

January 29, 2013 — FDA Issues Final Rule on Current Good Manufacturing Practice Requirements for Combination Products

January 29, 2013 — FDA Announces 2013 Generic Drug Active Pharmaceutical Ingredient and Finished Dosage Form Facility User Fee Rates

January 29, 2013 — New FDA Draft Guidance Addresses Combination Product Postapproval Modification Submissions

January 14, 2013 — Obama Administration's Regulatory Agenda Points to Busy 2013 for HHS

January 11, 2013 — FDA Requests Comments on Review of Medical Device Submissions

January 11, 2013 — FDA Issues Final Guidance Documents on Drug and Medical Device Submissions

January 11, 2013 — FDA Releases Draft Guidance Documents on Providing Submissions in Electronic Format

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

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

January 11, 2013 — FDA To Hold Workshop on Accessible Standardized Medical Device Labeling (April 29-30)

December 18, 2012 — FDA Issues Two New Draft Guidance Documents Related to the Conduct of Clinical Trials

December 18, 2012 — New FDA Draft Guidance Documents Address Product Safety and Risk Minimization

November 28, 2012 — FDA Addresses Food and Drug Administration Safety and Innovation Act (FDASIA) Implementation

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 31, 2012 — FDA Issues Generic Drug User/Backlog Fee Notices

October 16, 2012 — GAO Flags Concerns about Implantable Medical Device Information Security

October 16, 2012 — OIG Examines Dietary Supplement Claims, Registration with FDA

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

September 27, 2012 — Generic Drug User Fee Fix Cleared by Congress

September 27, 2012 — FDA Meetings on Patient-Focused Drug Development Initiative

September 6, 2012 — FDA Final Rule Implementing Device Registration and Listing Requirements

September 6, 2012 — Draft Guidance Regarding Self-Identification of Generic Drug Facilities and Q&A on Generic Drug User Fee Amendments

September 5, 2012 — FDA Establishes FY 2013 User Fee Rates for Biosimilars and Prescription Drugs

September 5, 2012 — FDA Guidance on FY 2013 Medical Device User Fee Small Business Qualification and Certification

September 5, 2012 — FDA Issues Guidance for Comment on Refuse to Accept Policy for 510(k)s

July 31, 2012 — Medical Device User Fee Rates for FY 2013

July 31, 2012 — FDA Issues Draft Guidance Regarding Acceptance & Filing Review for PMA Applications

July 16, 2012 — FDA Proposes Unique Device Identification System for Medical Devices

July 16, 2012 — FDA Draft Guidance the Medical Device Pre-Submission Program/Meetings with FDA Staff

July 16, 2012 — FDA Small Entity Compliance Guidance: Toll Free Number Labeling for Drugs

July 16, 2012 — FDA Draft Guidances Describe Product-Specific Bioequivalence Recommendations

July 16, 2012 — FDA Draft Guidance Document on Transferring Clinical Investigation Oversight to Another IRB

July 16, 2012 — FDA Guidance Addresses Genotoxicity Testing and Data Interpretation for Human Drugs

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

June 18, 2012 — OIG Examines Scientific Disagreements at CDRH Regarding Medical Device Reviews

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 Final Rule on Disqualification of Clinical Investigators

May 11, 2012 — FDA Issues Final Rule on Sterility Testing of Biological Products

May 11, 2012 — FDA Guidance on Medical Device Pre-market Approval

May 11, 2012 — FDA Seeks Information on Risks, Benefits of Metal-on-Metal (MoM) Hip Replacements

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

May 11, 2012 — International Collaboration Highlighted in FDA Global Engagement Report

April 23, 2012 — GAO Examines FDA Device Review Process

April 2, 2012 — House Approves IPAB Repeal/Medical Liability Reform Legislation

March 30, 2012 — FDA Announces Delayed Enforcement of ACA Drug Sample Distribution Reporting Requirement

March 29, 2012 — Congressional Health Policy Hearings

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 29, 2012 — Draft FDA Guidance Targets Direct-to-Consumer Television Marketing

March 14, 2012 — FDA Issues Three Draft Guidance Documents on Biosimilar Product Development; Announces May 11 Public Hearing

March 14, 2012 — FDA Draft Guidance on Safety Data Collection for Late Stage Premarket & Postmarket Investigations

March 14, 2012 — Congressional Hearings on Drug Issues.

March 14, 2012 — FDA Public Hearing Regarding Regulation of Clinical Trials (April 23-24)

February 13, 2012 — FDA Issues Guidance on New Informed Consent Requirements

February 10, 2012 — Final Rule Regarding Labeling Requirements for Products Held in Strategic National Stockpile

February 10, 2012 — FDA and Industry Reach Agreement in Principle on Medical Device User Fees

February 10, 2012 — FDA Q&A/Draft Guidance for Industry Related to PET Drug Products

February 10, 2012 — FDA Report on Exploratory Program to Increase Access to Agency Compliance and Enforcement Data

February 10, 2012 — February Congressional Health Policy Hearings

January 25, 2012 — Fall 2011 Regulatory Agenda (Belatedly) Released

January 25, 2012 — FDA Seeks Comments on Prescription Drug Promotion Survey

January 25, 2012 — FDA Completes Work on Three Drug User Fee Programs

January 25, 2012 — FDA Guidance on Product Name Placement in Advertising and Promotional Labeling

January 25, 2012 — E&C Health Subcommittee Plans FDA User Fee Hearings in February

January 23, 2012 — E&C Health Subcommittee Plans FDA User Fee Hearings in February

January 5, 2012 — GAO Report on Pediatric Medical Devices

January 4, 2012 — FDA Rule Expands Drug Manufacturer Notification Requirements for Potential Drug Shortages

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

December 29, 2011 — FDA Issues Draft Guidance Regarding Evaluation of Sex Differences in Medical Device Clinical Studies

December 29, 2011 — FDA Provides Draft Guidance on Evaluating Substantial Equivalence in Premarket Notifications

December 29, 2011 — FDA Guidance Regarding CDRH Appeals Process

December 13, 2011 — FDA Publishes Notice on Biosimilar Biological Product User Fees

December 13, 2011 — FDA Draft Guidance on Artificial Pancreas Device Systems, Hepatitis B Screening of Blood/Blood Components

December 12, 2011 — FDA Public Meeting on Generic Drug User Fees (Dec. 19)

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

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

October 28, 2011 — Correction Notice on CMS/FDA Parallel Review Pilot Program

October 25, 2011 — FDA Proposes Amendments to Orphan Drug Rules

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

October 14, 2011 — FDA Issues Draft Guidance to Clarify De Novo Classification Process

October 14, 2011 — FDA Seeks Comments on Proposal to Increase Transparency

September 26, 2011 — PDUFA Reauthorization Meeting (Oct. 24)

September 26, 2011 — Draft FDA Guidance on Exculpatory Language in Informed Consent

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

September 1, 2011 — HHS Issues Final Plan to Reduce Regulatory Burdens

September 1, 2011 — FDA Issues Strategic Plan for Regulatory Science