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

The Food and Drug Administration (FDA) is seeking comments on a planned "Experimental Study of the Impact of Coupons Embedded in Direct-to-Consumer Prescription Drug Print Advertisements." According to the FDA notice, the study will examine the impact of the presence of coupons offering price incentives or rebates on consumers' perceptions of product risks and benefits in direct-to-consumer (DTC) print ads. The FDA acknowledges, however, that "it does not actually regulate the dollar or other incentive amount of coupons, price incentives, or rebate offers with respect to how they affect the price of prescription drugs or biological products." Comments will be accepted until February 13, 2009.  

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The FDA Office of Orphan Product Development has announced grants to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. Grants are available for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Of the estimated FY 2010 funding ($14.1 million) for this program, approximately $10 million will fund noncompeting continuation awards, and approximately $4.1 million will fund 10 to 12 new awards, subject to availability of funds. 

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The Food and Drug Administration (FDA) is announcing an opportunity for public comment on a planned FDA study examining consumer comprehension of inclusion of a toll-free number to report side effects in direct-to-consumer (DTC) prescription drug television advertisements. Comments will be accepted until January 26, 2009. 

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On November 24, 2008, the Food and Drug Administration (FDA) announced the availability of a draft guidance document entitled “Contents of a Complete Submission for the Evaluation of Proprietary Names.” The document is intended to help prevent medication errors by assisting industry in the submission of complete product information that will enable FDA to evaluate the safety of proposed proprietary drug and biological product names. In addition, FDA intends to use this information in the assessment of promotional aspects of proposed proprietary names. The FDA will accept comments on the draft until January 23, 2009.   

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Separately, on November 18, 2008, the FDA announced the availability of draft guidance entitled “Process Validation: General Principles and Practices.” The FDA is revising related May 1987 guidance to promote a “lifecycle approach” to process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients. Comments will be accepted until January 20, 2009.

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On November 12, 2008, the Food and Drug Administration (FDA) issued a direct final rule to adjust for inflation the maximum civil money penalty (CMP) amounts for the various CMP authorities under FDA jurisdiction, as required by the Federal Civil Penalties Inflation Adjustment Act. The rule does not adjust new CMPs enacted by the Food and Drug Administration Amendments Act of 2007. The FDA is using direct final rulemaking for this action because the agency expects no significant adverse comment on the rule. However, the agency also is concurrently issuing the rule in proposed form and soliciting comments on the direct rule. If significant adverse comments are received, the FDA will withdraw the final rule and address the comments in a subsequent rulemaking. The rule is effective March 27, 2009, unless the FDA receives significant adverse comment by January 26, 2009. Comments will be accepted on the proposed rule until December 26, 2008.

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The FDA published a notice November 13, 2008 requesting written notification of any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on Center for Biologics Evaluation and Research (CBER) public advisory committees. The FDA also is soliciting nominations for nonvoting industry representatives to serve on the following CBER public advisory committees: the Cellular, Tissue and Gene Therapies Advisory Committee; the Vaccines and Related Biological Products Advisory Committee; and the Transmissible Spongiform Encephalopathies Advisory Committee. Notifications of interest and nominations are due December 15, 2008. 

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On October 28, 2008, the Food and Drug Administration (FDA) published a final rule requiring a statement to be included on certain human drug product labeling that provides a toll-free number for reporting side effects and specifies that the number is not intended to be used for medical advice. The rule, which confirms a January 3, 2008 interim final rule on this issue, implements provisions of the Best Pharmaceuticals for Children Act and the Food and Drug Administration Amendments Act of 2007. The compliance date for the final rule is July 1, 2009 (rather than the January 1, 2009 compliance date anticipated under the interim final rule). 

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On September 29, 2008, the Food and Drug Administration (FDA) published a direct final rule  requiring holders of a new drug application (NDA) to submit certain information regarding authorized generic drugs in an annual report .  The rulemaking is part of the agency’s implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which requires that FDA publish a list of all authorized generic drugs included in an annual report since 1999, and that the agency update the list quarterly.  The agency is publishing the requirement as a direct final rulemaking because it does not expect significant adverse comment on the rule. As part of the administrative requirements for a direct final rule, the agency is concurrently issuing a proposed rule and soliciting comments and, if any significant adverse comment is received, the FDA will withdraw the direct final rule and address the comments in a subsequent rulemaking.  If there is no significant adverse comment, the direct final rule will automatically become effective February 11, 2009.  Comments will be accepted until December 15, 2008, although comments on related information collection provisions are due October 29, 2008.

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On September 8, 2008, the Food and Drug Administration (FDA) published a final rule amending its current good manufacturing practice (CGMP) requirements for finished pharmaceuticals, effective December 8, 2008. In particular, the rule revises CGMP requirements concerning aseptic processing, verification of performance of operations by a second individual, and the use of asbestos filters. 

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The FDA has announced the availability of additional draft and revised draft product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). FDA will accept comments on the recommendations until December 4, 2008. Separately, the FDA has released draft guidance entitled “M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.'' The document, which discusses the types of nonclinical studies and their relation to the conduct of human clinical trials and marketing authorization for pharmaceuticals, is intended to facilitate the timely conduct of clinical trials and reduce the unnecessary use of animals and other drug development resources. The FDA is requesting comments on the draft guidance by October 20, 2008.

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On August 22, 2008, the FDA published a final rule amending its regulations regarding changes to an approved new drug application, biologics license application, or medical device premarket approval application.  Specifically, the rule provides that a labeling change to an approved product to reflect "newly-acquired information" that adds or strengthens a contraindication, warning, precaution, or adverse reaction, may be made prior to FDA approval upon the submission of a "Changes Being Effected" or "CBE" supplemental only if there is sufficient (reasonable) evidence of a causal association with the use of the drug, biologic, or device.  In a change from the January 16, 2008 proposed rule, CMS is revising the definition of “newly acquired information” to clarify that data, whether derived from reports of adverse events or from new clinical studies or new analyses of previously submitted data (e.g., meta-analyses) needs to be of a “different type or greater severity or frequency than previously included in submissions to FDA.”  This standard could limit the circumstances under which a company can make changes without prior FDA approval.  The rule is viewed by many as FDA's attempt to address preemption questions raised in state product liability lawsuits against holders of marketing applications for their failure to amend labeling before or without FDA's approval.  The rule is effective September 22, 2008.

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On August 4, 2008, the Food and Drug Administration (FDA) released a series of final guidance documents designed strengthen its management of FDA advisory committees. Among other things, the new policies include stricter limits on financial conflicts of interest for committee members (including a $50,000 cap on the personal financial interest an advisor may have in all companies potentially affected by a meeting), revised voting procedures, strengthened processes for disclosing information regarding advisory committee members’ financial interest information; and procedures for developing and distributing briefing materials considered at advisory committee meetings. The FDA also released draft guidance regarding factors the FDA considers in deciding whether to refer a matter to an advisory committee for consideration.  Notices regarding the guidance documents also were published in the Federal Register.

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On August 1, 2008, the FDA posted its FY 2009 prescription drug user fee rates and medical device user fee rates. 

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On August 6, 2008, the FDA published a notice soliciting comments on its plan to conduct an “Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Broadcast Advertisements.”  Specifically, the FDA will create a variety of television ads for a fictitious medication and study whether visual or other distractions impact a viewer’s comprehension of the ad’s risk and benefit information. The FDA may use this data to determine, among other things, whether additional guidance is needed on how broadcast ads present a prescription drug’s risks and benefits. Comments on the study will be accepted until September 5, 2008.

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On July 16, 2008, the House Energy and Commerce Committee approved amended versions of H.R. 6432, the "Animal Drug User Fee Amendments of 2008," and H.R. 6433, the "Animal Generic Drug User Fee Act of 2008." 

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On July 15, 2008, the Food and Drug Administration (FDA) published a final rule amending the current good manufacturing practice (CGMP) regulations for human drugs and biological products to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements.  FDA will continue to exercise oversight of the manufacturing of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications. In addition, FDA is announcing the availability of a guidance document on "CGMP for Phase 1 Investigational Drugs," which sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs.  FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality.  This action will also streamline and promote the drug development process, according to FDA.

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 On July 15, 2008, FDA is publishing a final rule amending the current good manufacturing practice (CGMP) regulations for human drugs and biological products to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacturing of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND). In addition, FDA is announcing the availability of a guidance document on "CGMP for Phase 1 Investigational Drugs," which sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs. FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality. This action also will streamline and promote the drug development process, according to FDA.

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On July 9, 2008, the House Energy and Commerce Subcommittee on Health approved H.R. 6432, the "Animal Drug User Fee Amendments of 2008," and H.R. 6433, the "Animal Generic Drug User Fee Act of 2008." Additional information is available here.

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On July 2, 2008, the Food and Drug Administration (FDA) announced that it is inviting pharmaceutical companies to volunteer to participate in a pilot program designed to facilitate agency review of quality-by-design, risk-based approaches for manufacturing biotechnology products. The pilot involves the submission of quality (e.g., chemistry, manufacturing, and controls) information for biotechnology products in an Expanded Change Protocol, focusing on products reviewed by FDA's Office of Biotechnology Products (OBP) within the Center for Drug Evaluation and Research. The pilot is open to original submissions of and supplements to biologic license applications or new drug applications reviewed by OBP. Requests to participate in the pilot program must be submitted by September 30, 2009, and comments on the program can be submitted through 2008.

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The FDA has released its “Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan,” which describes the FDA’s vision for improving the automation of business processes and maintaining information systems that support the review process of human drug applications. Comments on the plan may be submitted at any time. Details are available here.

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The FDA has released final guidance to industry on individual product bioequivalence recommendations. 

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On June 19, 2008, the House of Representatives approved a modified version of emergency Iraq and Afghanistan appropriations legislation (H.R. 2642) that also includes funding for a number of domestic priorities. Among other things, the bill would extend a current moratorium on implementation of certain Medicaid regulations and block additional rules through April 1, 2009. The rules affected by the legislation involve: payments to public safety net institutions; coverage of rehabilitation services; school-based administrative and specialized medical transportation services for children; graduate medical education payments; case management services; and state provider tax laws. To finance the repeal, the bill would extend an electronic asset verification demonstration for Medicaid applicants and beneficiaries, and reduce balances in the Physician Assistance and Quality Improvement (PAQI) Fund. The bill also provides an additional $150 million for Food and Drug Administration food and medical product safety efforts, and $25 million annually for Medicaid anti-fraud activities.  The bill does not include restrictions on physician ownership of hospitals, as had been included in an earlier Senate version of the measure. The White House has announced its support for the House bill, although it is unclear at this time whether the Senate will adopt this version or propose additional revisions.

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On June 13, 2008, the Food and Drug Administration (FDA) published a direct final rule removing a requirement for medical device baseline reports that the agency deems no longer necessary. Currently, device manufacturers provide baseline reports when they submit the first adverse event report for a device model.  Because most of the information in these baseline reports is also submitted to FDA in individual adverse event reports, FDA is removing the requirement for baseline reports to streamline reporting requirements.  The rule will become effective October 27, 2008, unless a comment is submitted within 75 days raising a significant objection to the change.  Therefore, FDA also has published a companion proposed rule to provide a procedural framework to finalize the rule in the event the agency withdraws the final rule in response to adverse comments. The FDA will accept comments on both documents through August 27, 2008.

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The OIG has released a report entitled "The Food and Drug Administration's Generic Drug Review Process". The OIG found that FDA disapproved 96 percent of original Abbreviated New Drug Applications (ANDA) under review in 2006 because they did not meet FDA review standards, and that many reviews exceeded the statutory review timeframe. In response, the FDA stated that it is implementing process improvements to address these areas.

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On May 29, 2008, the Food and Drug Administration (FDA) published a proposed rule to make major revisions to drug label requirements related to the use of a drug during pregnancy and breast feeding. Among other things, the agency is proposing to require that labeling include a summary of the risks of using a drug during pregnancy and lactation and a discussion of the data supporting that summary. The labeling also would include relevant clinical information – presented in sections on fetal risks, clinical considerations, and data – designed to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and/or lactation. Current letter categories would be removed from the pregnancy section of drug labeling. Certain newly approved drugs would use the new pregnancy and lactation labeling format, while labeling requirements for previously approved drugs will be phased-in. The FDA is accepting comments on the proposal until August 27, 2008. Additional information is posted here.

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On May 22, 2008, the Food and Drug Administration (“FDA”) announced plans for what it is calling the “Sentinel System” -- a new, national electronic health information surveillance system to track the performance and safety of medical products once they are on the market. According to the FDA, the Sentinel System will be created through public-private partnerships and will capitalize on existing large electronic claims and medical records data sources maintained by private and government entities that agree to participate in this nationwide effort. A Reed Smith bulletin discussing this initiative in greater detail is posted here.

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The FDA has published a final rule modifying the requirements for acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) as support for an IND or application for marketing approval for a drug or biological product. The rule abandons the requirement that sponsors use the Declaration of Helsinki as the standard for ensuring protections for human subjects and, in its place, requires foreign studies to be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee. The rule is effective October 27.

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The FDA has released a final guidance document entitled “Interactive Review for Medical Device Submissions: 510(k)s, Original Premarket Approval Applications (PMAs), PMA Supplements, Original Biologic License Applications (BLAs), and BLA Supplements”.

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The FDA has released two draft guidance documents regarding the labeling of dietary supplements and the labeling of nonprescription human drug products marketed without an approved application, as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. Comments will be accepted on both documents until March 3, 2008. For more information on the first draft, click here.  For more information on the second draft, click here. 

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