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The FDA has released revised draft guidance entitled “Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1.” This guidance is intended to assist industry in complying with the labeling requirements for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application established by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. In an earlier version of the guidance issued January 2, 2008, the FDA stated that it intended to begin enforcing the labeling requirements for OTC drug products marketed without an approved application that are labeled on or after January 1, 2009; because the agency is still finalizing the guidance, the revised draft extends the enforcement date until January 1, 2010. Separate guidance regarding compliance with the labeling requirements for dietary supplements also has been released.

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The FDA has released draft guidance on “Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches.” The document reflects the agency's views on genotoxic and carcinogenic impurities in drug substances and drug products, including biologic products regulated by the Center for Drug Evaluation and Research. It also provides recommendations on how to evaluate the safety of these impurities during clinical development and for marketing applications, including additional testing and exposure threshold recommendations when genotoxic or carcinogenic impurities are present. The draft guidance addresses synthetic impurities and degradants in drug substances, but not the genotoxicity or carcinogenicity of actual drug substances or intended drug product ingredients. This draft guidance also applies to known starting materials or anticipated reaction products. The FDA will accept comments on the guidance through February 17, 2009. 

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The FDA has issued guidance on “Modifications to Devices Subject to Premarket Approval (PMA)--the PMA Supplement Decision-Making Process,” which is designed to help industry determine the type of regulatory submission that may be required when a device subject to PMA is modified.  

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The FDA has released guidance for manufacturers of new and generic pharmaceutical products on the definition of an orally disintegrating tablet (ODT). The FDA notes that manufacturers have developed products that can be ingested simply by placing them on the tongue, eliminating the need to chew the tablet, swallow an intact tablet, or take the tablet with liquids. As new products have been developed using different technology and formulations, many of these later products exhibited wide variation in product characteristics from the initial products. Because this shift in product characteristics can affect suitability for particular uses, the agency developed this guidance for industry.

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On December 1, 2008, the HHS Office for Human Research Protections (OHRP), Office of Public Health and Science, announced it is requesting public comments on a draft guidance document entitled “Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued.” The draft document is intended primarily for institutional review boards (IRBs), investigators, and funding agencies that may be responsible for the review or oversight of human subject research conducted or supported by HHS. OHRP will accept comments on the draft until January 30, 2009. In a related development, the FDA released guidance on “Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials,” which clarifies FDA's position that it is critical that data be retained from trial participants who decide to discontinue participation in a clinical study of an investigational product, who are withdrawn by their legally authorized representative, as applicable, or who were discontinued from participation by the clinical investigator. This Level 1 guidance is being issued for immediate implementation to prevent the potential loss of important clinical trial data.; if comments are received, the agency will review the comments and revise the guidance if appropriate. 

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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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The FDA has released for public comment draft guidance entitled “Submission of Patent Information for Certain Old Antibiotics.” The document describes the agency's current thinking on the implementation of certain provisions of the Q1 Program Supplemental Funding Act (the Q1 Act) that concern old antibiotics and addresses which sponsors of new drug applications must submit patent information under the Q1 Act by December 5, 2008. Comments on the guidance will be accepted until February 2, 2009. 

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The FDA has announced the availability of a document entitled “Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics.” The guidance, which applies to biological products subject to licensure under the U.S. Public Health Service Act, describes the licensing strategies for meeting the increased need for flexible manufacturing arrangements, such as short supply arrangements, divided manufacturing arrangements, shared manufacturing arrangements, and contract manufacturing arrangements.

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On December 3, 2008, the FDA announced it is teaming with WebMD to expand consumer access to FDA safety alerts and other public health information. Among other things, the partnership includes a new online consumer health information resource on WebMD.com where consumers can access information on the safety of FDA-regulated products. 

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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 24, 2008, the Department of Health and Human Services (HHS) published its semiannual regulatory agenda, outlining planned regulatory initiatives in a number of health policy areas. A separate document listing major Administration regulatory initiatives and priorities, including health policy priorities, also is available.

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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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HHS announced it is preparing to open FDA offices in China, India, Europe, and Latin America before the end of 2008 to beef up efforts to ensure the safety of imported food and medical products. FDA personnel overseas will be tasked with providing technical advice to local authorities and industries, conducting additional inspections, and working with government agencies and private sector entities interested in developing certification programs. This initiative is part of the federal government’s Import Safety Action Plan. 

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On October 22, 2008, the Government Accountability Office (GAO) issued a report entitled "Drug Safety: Better Data Management and More Inspections Are Needed to Strengthen FDA's Foreign Drug Inspection Program." Among other things, the GAO found that: FDA databases contain inaccurate information on foreign establishments subject to inspection; FDA inspects relatively few foreign establishments each year to assess the manufacturing of drugs currently marketed in the United States; and FDA’s identification of serious deficiencies has led foreign establishments to take corrective actions, but inspections to determine continued compliance are not always timely. The GAO recommends that FDA improve the data that it uses to manage its foreign inspection program, conduct more inspections of foreign establishments, and ensure more timely inspection of foreign establishments where FDA has identified serious deficiencies. HHS agreed that FDA should conduct more foreign inspections, and discussed other FDA oversight initiatives, such as database improvements.

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The Food and Drug Administration (FDA) has released a draft guidance document on “Potency Tests for Cellular and Gene Therapy Products.” The document is designed to provide manufacturers of cellular and gene therapy products with recommendations for developing tests to measure potency to support an Investigational New Drug Application (IND) or a Biologics License Application (BLA). FDA will accept comments on the guidance through January 7, 2009. 

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The Government Accountability Office (GAO) has issued a report examining the FDA’s advisory committee processes. Specifically, the GAO examined: (1) how FDA recruited individuals for membership and evaluated candidates for potential conflicts of interest, (2) barriers that were reported to recruiting qualified individuals to serve on committees, and (3) the proportion of standing and temporary members, and the frequency with which members with conflict of interest determinations participated in meetings. 

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The FDA released for public comment draft guidance on the regulation of genetically engineered (GE) animals. The guidance document is intended to clarify the FDA's regulatory authority in this field, as well as the requirements and recommendations for producers of GE animals and products derived from GE animals.   Among other things, the guidance requires producers to demonstrate that food from the GE animal is safe to eat if the GE animal is intended for food use. The guidance also describes a sponsor's responsibility in meeting the National Environmental Policy Act’s environmental assessment requirement.   The draft guidance also describes how the FDA may exercise enforcement discretion with regard to GE animals. The FDA will accept comments on the guidance through November 18. 

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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 October 1, 2008, the HHS Office of Inspector General (OIG) released its FY 2009 Work Plan, which discusses planned OIG audit, inspection, and investigative initiatives affecting virtually every type of health care provider and supplier.

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The Food and Drug Administration (FDA) has published a notice announcing animal drug and generic animal drug user fee rates and payment procedures for fiscal year 2009.

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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 September 5, 2008, the FDA posted its first quarterly report listing 20 specific drugs that are being evaluated for potential safety issues based on a review of reports in FDA's Adverse Event Reporting System, as mandated by the Food and Drug Administration Amendments Act of 2007. The FDA cautions that the appearance of a drug on this list does not mean that FDA has concluded that the drug has or causes the listed risk, nor does it suggest that healthcare providers should not prescribe or patients should not take the drug. If the FDA determines after further evaluation that the drug is associated with the risk, FDA could require labeling changes, require development of a Risk Evaluation and Mitigation Strategy (REMS), or gather additional data to better characterize the risk. 

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On July 30, 2008, the House of Representatives approved by a 326 to 102 vote an amended version of H.R. 1108, the “Family Smoking Prevention and Tobacco Control Act,” which would give the FDA the authority to regulate tobacco products.  The bill now moves to the Senate. Note that the President has threatened to veto the House version of the bill. 

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On August 1, 2008, the Senate approved H.R. 6432, the “Animal Drug User Fee Amendments of 2008,” which would to revise and extend the FDA’s animal drug user fee program, establish a program of fees relating to generic new animal drugs, and make certain technical corrections to the Food and Drug Administration Amendments Act of 2007. The House approved the measure on July 30, and it now awaits the President’s signature.

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