Health Industry Washington Watch : Washington DC Healthcare Industry Law Firm : Reed Smith : Health Industry Washington Watch : Regulations, Medicare/Medicaid, Governmental Organizations

This post was written by Kevin Madagan and Debra McCurdy.

Key members of the Senate Health, Education, Labor, and Pensions Committee have released a bipartisan draft legislative proposal intended to improve drug distribution security. The legislation addresses, among other things: lot-level product tracing requirements for “downstream” pharmaceutical supply chain members (drug manufacturers, repackagers, wholesale distributors, and dispensers); a requirement that manufacturers serialize prescription drugs at the unit level; national licensure standards for wholesale distributors and third-party logistics providers; a requirement that members of the supply chain only transact with registered or licensed entities; and preemption of state product tracing requirements, including paper or electronic pedigree systems. The lawmakers will accept comments on the draft legislation until April 26, 2013. In a related development, the House Energy and Commerce Subcommittee on Health has scheduled an April 25 hearing on "Securing Our Nation's Prescription Drug Supply Chain,” which will focus on a House companion version of the draft “track and trace” legislation intended to secure pharmaceutical distribution. 

Update:  On May 8, 2013, the House Energy and Commerce Health Subcommittee approved by voice vote an amended version of its “track and trace” legislation intended to secure pharmaceutical distribution.

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This post was written by Jennifer Pike.

The FDA is seeking comments on draft guidance related to clinical trial enrichment: Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products. The document is designed to provide guidance to industry on enrichment strategies that can be used in clinical trials intended so support effectiveness and safety claims in NDAs and BLAs. According to FDA, enrichment could lead to smaller studies, lower development costs, and help develop more personalized medicine. The guidance defines and discusses three types of enrichment strategies: decreasing heterogeneity, predictive enrichment, and prognostic enrichment. The guidance also discusses general clinical trial design considerations, provides examples of various potential clinical trial designs, and discusses potential regulatory considerations when using enrichment strategies in clinical trials. Comments may be submitted at www.regulations.gov until February 15, 2013.

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This post was written by Jennifer Pike.

The FDA has released two final guidance documents intended to help sponsors and investigators comply with safety reporting requirements for IND applications and bioavailability (BA) and bioequivalence (BE) studies: Safety Reporting Requirements for INDs and BA/BE Studies, and Safety Reporting Requirements for INDs and BA/BE Studies – Small Entity Compliance Guide. Comments regarding both guidance documents may be submitted at any time.

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On December 19, 2012, the FDA is hosting a public meeting entitled “Framework for Pharmacy Compounding: State and Federal Roles” (the meeting also will be webcast). While the FDA acknowledges that “the States play a critical role in the oversight of traditional pharmacy compounding,” the FDA observes that “a category of “non-traditional” compounding has evolved in the last decade that FDA believes requires additional oversight.” According to the notice, the FDA is working with Congress to consider new authorities regarding these “non-traditional” compounding pharmacies. In addition to holding the public meeting, the FDA is soliciting comments on several specific questions related to federal and state roles in the regulation of pharmacy compounding, such as (1) whether the states currently are able to provide oversight of pharmacy compounding and consumer protection; (2) what the federal role should be in regulating higher risk pharmacy compounding such as compounding high-volumes of drugs for interstate distribution; and (3) whether or not there is a role for the states in enforcing a federal standard for "nontraditional" compounding. Comments are due by January 18, 2013.

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On November 14, 2012, the House Science, Space, and Technology Committee is holding a hearing entitled “Is 'Meaningful Use' Delivering Meaningful Results -- An Examination of Health Information Technology Standards and Interoperability.”  Two hearings are scheduled to examine the recent outbreak of fungal meningitis: a November 14 House Energy and Commerce Oversight Subcommittee hearing on "The Fungal Meningitis Outbreak: Could It Have Been Prevented?"  and a November 15 Senate Health, Education, Labor, and Pensions Committee hearing entitled “Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak.”

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President Obama has signed into law a temporary spending bill (H.J.Res. 117) to fund the government until March 27, 2013 in light of Congress’ failure to reach agreement on the regular appropriations bills before the start of the new fiscal year on October 1, 2012. In addition, on October 5, 2012, President Obama signed H.R. 6433, the FDA User Fee Corrections Act of 2012 (which allows the FDA to collect all generic drug user fees authorized by the recently-enacted FDA Safety and Innovation Act for FY 2013), and H.R. 4223, the Safe Doses Act (which seeks to combat theft of prescription drugs and other medical products). Our previous summaries of these bills are available here.

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On September 21, 2012, the Senate approved H.R. 4223, the Safe Doses Act, which seeks to combat theft of prescription drugs and other medical products. In particular, the legislation would: increase sentences for the theft, transportation, and storage of medical product cargo; enhance penalties for knowingly obtaining stolen medical products for resale into the supply chain; increase sentences when injury or death results from use of the product or where the defendant is employed by an organization in the supply chain for the pre-retail medical product; expand law enforcement tools such as wiretaps; and provide restitution to victims injured by stolen medical products. The bill, which was approved by the House in June, now is cleared for the President’s signature. 

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Recent Congressional hearings have focused on the following health policy issues, among others:  

• A House Ways and Means Health Subcommittee hearing entitled “Physician Organization Efforts to Promote High Quality Care and Implications for Medicare Physician Payment Reform";
• A Senate Commerce, Science and Transportation Committee hearing on short-supply, “gray market” prescription drugs; and
• A House Oversight and Government Reform Committee hearing on the Obama Administration’s Medicare Advantage Quality Bonus Payment Demonstration. The Panel also has scheduled an August 2 hearing on IRS enforcement of the ACA’s tax provisions.

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On June 26, 2012, the Senate gave final approval to S. 3187, the Food and Drug Administration Safety and Innovation Act, following House action on June 20, 2012. The sweeping, bipartisan legislation would reauthorize the Prescription Drug User Fee Act and the Medical Device User Fee Act, and authorize user fee programs for generic drugs and biosimilar drugs. As part of the drug and device user fee reauthorization process, the FDA would commit to certain performance goals and to fostering more interaction and predictability between industry and FDA during the review process. In addition, the bill would, among other things: take a variety of steps to alleviate drug shortages and protect the drug supply chain (although it does not include a national track-and-trace program); permanently authorize the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act; offer incentives for the development of new qualified infectious disease products; promote expedited review of “breakthrough therapy” drugs; and make a variety of FDA administrative reforms. The President is expected to sign the bill. 

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On June 21, 2012, HHS announced two pilot projects that seek to reduce prescription drug abuse through prescription drug monitoring programs (PDMPs) -- electronic databases that collect, monitor, and analyze electronically-transmitted prescribing and dispensing data submitted by pharmacies and dispensing practitioners. The pilot projects, which will take place in Indiana and Ohio, will demonstrate how hospital emergency department staff can receive a patient’s controlled substance prescription history and how this information affects clinical decision making.

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On June 15, 2012, CMS issued instructions to state survey agencies on the “Safe Use of Single Dose/Single Use Medications to Prevent Healthcare-Associated Infections.” While CMS is not changing its policy regarding the reuse of single-dose vials or single use vials (collectively referred to as “SDVs”), CMS outlined conditions under which certain health care providers may repackage SDVs into smaller doses, each intended for a single patient. The policy clarification is prompted by recent drug shortages and the interest of facilities in reducing waste of SDV medication that exceeds the needed dosage for a single patient. The policy applies to a number of provider types, including nursing facilities, hospitals, ASCs, hospices, and HHAs.

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On June 18, 2012, the House of Representatives approved H.R. 3668, the Counterfeit Drug Penalty Enhancement Act, which would increase penalties for trafficking in counterfeit drugs. The legislation now moves to the Senate.

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On June 6, 2012, the House Judiciary Committee approved H.R. 3668, the Counterfeit Drug Penalty Enhancement Act, which would increase penalties for trafficking in counterfeit drugs. The House is scheduled to vote on the bill on June 18.  The panel also approved H.R. 4223, the Safe Doses Act, which seeks to combat theft of prescription drugs and other medical products.  

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On May 30, 2012, the House of Representatives voted 387-5 to approve H.R. 5651, the Food and Drug Administration Reform Act. The House bill would reauthorize the Prescription Drug User Fee Act and the Medical Device User Fee Act, and authorize user fee programs for generic drugs and biosimilar drugs. As part of the drug and device user fee reauthorization process, the FDA would commit to certain performance goals and to fostering more interaction, predictability, and certainty between industry and FDA. In addition, the bill would: take a variety of steps to protect the drug supply chain and alleviate drug shortages; permanently authorize the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act; make a variety of FDA administrative reforms (including changes to the guidance process and conflict of interest rules); and revise the medical device and drug review processes. On May 24, the Senate approved its version of the legislation, S. 3187, the Food and Drug Administration Safety and Innovation Act, by a vote of 96-1. A conference committee will be appointed to resolve differences between the House and Senate versions of the bills. 

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On May 10, 2012, the House Energy and Commerce Committee unanimously approved H.R. 5651, the Food and Drug Administration Reform Act. The legislation would reauthorize the Prescription Drug User Fee Act and the Medical Device User Fee Act, and it authorizes user fee programs for generic drugs and biosimilars. As part of the drug and device user fee reauthorization process, the FDA would commit to certain performance goals and to fostering more interaction, predictability, and certainty between industry and FDA. In addition, the bill: permanently authorizes the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act; makes a variety of FDA administrative reforms (including changes to the guidance process and conflict of interest rules); make various reforms to the medical device and drug review processes; and take steps intended to alleviate drug shortages. On April 25, the Senate Health, Education, Labor and Pensions (HELP) Committee also approved bipartisan legislation, the Food and Drug Administration Safety and Innovation Act, to authorize FDA user fees and address drug supply chain and drug shortage issues.

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This post was written by Erin A. Janssen.

According to an April 24, 2012 Center for Drug Evaluation and Research (CDER) report, a strengthened and modernized post-market drug safety program has resulted in a substantial improvement in FDA’s oversight of drugs once they reach the American public. The report, “Advances in FDA’s Safety Program for Marketed Drugs,” describes new scientific tools and enhanced capabilities that CDER contend give the same priority to post market drug safety monitoring as to premarket drug review. The report says CDER is also delivering earlier, more effective drug safety information to the public. CDER's efforts include the development of new scientific tools to enhance detection of potential drug safety issues that occur once a drug is on the market and new methods for planning, managing, tracking, and communicating about those issues.

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This post was written by Erin A. Janssen.

The FDA has released draft guidance entitled “Classifying Significant Postmarket Drug Safety Issues.”  This draft guidance describes FDA’s current approach to classifying a significant postmarket drug safety issue as a “priority” tracked safety issue (TSI) or a “standard” TSI, with the capability of elevating some priority TSIs to an “emergency” status. The Center for Drug Evaluation and Research seeks to establish a formal framework for assessing the relative urgency of TSIs, so that CDER can direct resources more effectively toward the issues that pose the greatest potential risk for patients. This framework will classify TSIs as “priority” or “standard” for CDER review. In addition, the Center will recognize a special “emergency” category for certain priority TSIs. The use of a formal framework is intended to ensure that staff working in different offices across CDER reaches similar conclusions about the relative urgency of TSIs. It also will inform CDER decisions about public drug safety communications, so that health care practitioners and patients receive timely information about safety risks with the greatest public health significance. Written comments are due May 8, 2012.

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This post was written by Erin A. Janssen.

The FDA has released draft guidance entitled “Drug Safety Information—FDA’s Communication to the Public,” which updates and revises March 2007 guidance on this issue.  It describes FDA’s current approach to communicating to the public important drug safety information, including emerging drug safety information, and the factors that influence when the information is communicated. In recent years, FDA has opted to make information on potential drug risks available to the public earlier, often while the Agency is still evaluating the data and determining whether any action is warranted. In the guidance, FDA expresses the belief that timely communication of important drug safety information will give health care professionals, patients, consumers, and other interested persons access to the most current information concerning the potential risks and benefits of a marketed drug, helping them to make more informed individual treatment choices. Written comments on the draft guidance should be submitted by May 8, 2012.

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On March 6, 2012, the Senate passed S. 1886, legislation to increase the maximum penalties for trafficking in counterfeit drugs. The legislation awaits House consideration.

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Recent health policy hearings include a House Judiciary Committee Crime Subcommittee hearing on “The Prescription Drug Epidemic in America” and a House Energy and Commerce Health Subcommittee hearing on “FDA User Fees 2012: Issues Related to Accelerated Approval, Medical Gas, Antibiotic Development and Downstream Pharmaceutical Supply Chain.”

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