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The FDA has released revised draft guidance entitled “Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the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 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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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 October 24, 2008, CMS issued a transmittal updating the Medicare Benefit Policy Manual to recognize the four authoritative compendia for use in the determination of a medically-accepted indication of drugs and biologicals used off-label in an anti-cancer chemotherapeutic regimen. The transmittal also modifies requirements for contractors to identify off-label uses that are supported by clinical research.

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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 AHRQ's Technology Assessment Program develops systematic reviews and health technology assessments at the request of CMS in order to inform national Medicare coverage policies. AHRQ has announced that beginning October 15, 2008, it will post draft Technology Assessment Program reports for public comment on its website.  In a related development, on October 14, 2008, AHRQ has announced that it will be releasing for public comment a draft White Paper on "Potential Conflict of Interest in the Production of Drug Compendia" on October 22, and comments will be accepted on the draft until November 5, 2008.

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On October 7, 2008, CMS pubished a final rule revising the definition of "multiple source drug" under the Medicaid program. The rule also responds to public comments received on the March 14, 2008 interim final rule with comment period. The final rule adopts the March 2008 interim final rule with the following change: in §447.205, paragraph (3)(i) of the definition of multiple source drug, the term "covered outpatient drug" is revised to read "drug product" and "listed product" respectively to reflect the statutory language. As noted in the interim final rule with comment period, to the extent that this rule may affect Medicaid reimbursement rates for retail pharmacies, it is subject to the injunction issued by the United States District Court for the District of Columbia in National Association of Chain Drug Stores et al. v. Health and Human Services. The rule is effective is effective November 6, 2008. 

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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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The Senate recently joined the House in approving H.R. 6353, the “Ryan Haight Online Pharmacy Consumer Protection Act,” which would prohibit the sale of controlled substances over the Internet without a valid prescription and subject on-line pharmacies to a series of new restrictions. Likewise, the Senate approved H.R. 6469, which would increase funding for the Organ Procurement and Transplantation Network. Both bills now await the President’s signature. In addition, President Bush has signed into law S. 1760, which reauthorizes the Healthy Start Initiative to provides grants to reduce infant mortality and improve maternal health.

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There has been a flurry of recent legislative activity as the 110^th Congress prepares to adjourn in the coming days. Congress has taken action on a wide range of health policy bills, addressing such issues as FDA drug and device approvals, internet pharmacy regulation, health care workforce issues, insurance coverage, and medical treatment, and patent protection for antibiotics.   Specifically, the following legislation has been approved by the House and Senate and now await the President’s signature:

• H.R. 6353, the “Ryan Haight Online Pharmacy Consumer Protection Act,” which would prohibit the sale of controlled substances over the Internet without a valid prescription and subject on-line pharmacies to a series of new restrictions.
• S. 3560, the “QI Program Supplemental Funding Act,” which would authorize an additional $45 million for the Medicare Qualifying Individuals (QI) program, which helps certain low-income individuals pay their Medicare Part B premiums. The legislation also includes provisions to modify the patent protections applicable to antibiotics and clarify the ability of generic drug companies to gain approval of and market generic antibiotics. In addition, the bill would expand the education activities under the Medicaid Integrity Program (MIP) and extend funding for the Medicare Improvement Fund to make improvements under the original Medicare program. 
• Several measures aimed at expanding disease research and information resources, including: H.R. 1157, which would authorize grants for the development and operation of research centers for the study of environmental factors that may be related to the etiology of breast cancer; H.R. 1532, which would reauthorize the Preventive Health Services Regarding Tuberculosis program; H.R. 5265, which would promote research into the causes and treatments of various forms of Muscular Dystrophy; S. 1810, to authorize the HHS Secretary to collect and disseminate information regarding Down syndrome or other prenatally or postnatally diagnosed diseases and to coordinate the provision of support services for those who receive a diagnosis of one of those diseases; and S. 1382, which would authorize funding for the establishment of a national registry for the collection and storage of data on amyotrophic lateral sclerosis (ALS).

 

• S. 2932, which would reauthorize the poison center national toll-free number, provide grants for poison centers, and expand poison prevention education efforts.
• S. 1760, which would reauthorize the Healthy Start Initiative, which provides grants to reduce infant mortality and improve maternal health.
• H.R. 1343, which would provide funding to enable health centers to serve medically underserved populations and reauthorize the National Health Service Corps Scholarship and Loan Repayment programs.

In addition, the following bills have been approved by the House but are awaiting Senate action.

• H.R. 1014, the Heart Disease Education, Analysis Research, and Treatment (HEART) for Women Act, which would require new drug, biologics, and device applications submitted to FDA to include any clinical data possessed by the sponsor that relates to safety or effectiveness by gender, age, and racial subgroups. This information would be posted on the internet. The bill also would authorize research and public health activities to reduce cardiovascular disease in women. 
• H.R. 6908, the “HIPAA Recreational Injury Technical Correction Act,” which would require timely disclosure of limitations and restrictions on coverage under group health plans.
• H.R. 758, which would require health insurers to cover minimum lengths of stay and secondary consultations for patients undergoing procedures to treat and diagnose breast cancer.
• H.R. 2583, the “Physician Workforce and Graduate Medical Education Enhancement Act ,” which would authorize a loan repayment program for hospitals to start a residency training program.
• H.R. 6568, which would expand research and educational activities related to pulmonary hypertension.
• H.R. 2994, which would direct the Department of Health and Human Services to establish a national pain care education outreach and awareness campaign.
• H.R. 6469, which would increase funding for the Organ Procurement and Transplantation Network.
• H.R. 5352, the “Elder Abuse Victims Act,” which would establish specialized elder abuse prosecution and research programs and activities to aid victims of elder abuse, provide training to prosecutors and other law enforcement related to elder abuse prevention and protection.
• H.R. 6901, which would improve treatment for methamphetamine addiction.

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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 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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CMS has updated its list of authorized compendia that may be used in determining medically-accepted indications of drugs and biologicals used off-label in an anti-cancer chemotherapeutic regimen under Medicare Part B. Specifically, CMS will add Elsevier Gold Standard’s Clinical Pharmacology compendium to the list of Medicare anti-cancer treatment compendia. Earlier this year, CMS approved the NCCN Drugs & Biologics Compendium and Thomson Micromedex DrugDex. More information is available here.

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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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