News Releases

FDA Pharamacogenomic Biomarker Database

Posted by cdavenport on Thursday Jul 5, 2012 Under Databases, Drug Safety, FDA, Genetic Toxicology, Regulatory

Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose. Drug labels may contain information on genomic biomarkers and can describe:

    • Drug exposure and clinical response variability
    • Risk for adverse events
    • Genotype-specific dosing
    • Mechanisms of drug action
    • Polymorphic drug target and disposition genes

This resource table lists FDA-approved drugs with pharmacogenomic information / biomarkers in their labels.

Source:  FDA

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FDA Resource for Approved Drug Information

Posted by cdavenport on Monday Jun 25, 2012 Under Databases, FDA, Preclinical, Regulatory

Ever wanted to know the ins and outs of almost every drug approved by the Food and Drug Administration since 1939?

By using the Drugs@FDA database, you can search for information about FDA-approved brand name and generic drugs and therapeutic biological products.  The database includes most of the drug products approved since 1939 and has drug labels, patient information, approval letters, and other information for most drug products approved since 1998.

Source:  FDA

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In order to keep our competitive edge, the Federal Drug Administration (FDA) is placing increased emphasis on strengthening both the field and application of regulatory science relative to pharmaceutical research, development, review, and post-market surveillance.  The FDA also has a mandate to recognize areas of unmet public health need and try to galvanize action to move appropriate new products through the pipeline and into the market.  The FDA has the responsibility, therefore, not just to review and approve products if the data support that decision, but also to follow these products once marketed to answer critical questions about efficacy and safety.  Examination of products across their life cycle enables not only the identification and analysis of emerging safety signals, but also facilitates the continual balancing of risks and benefits.

Research studies, both preclinical and clinical, that form the basis for approval of medical products are increasingly being performed in other countries and often in networks of other countries.   For this reason, international recognition of both the scientific appropriateness and ethical conduct of those studies becomes increasingly important to global regulatory bodies.  A key understanding is that if a safety concern develops for an approved drug, it does not necessarily reflect that a mistake was made.  It may instead reflect new emerging knowledge about that drug in practical use.  Regulatory safety has to be a dynamic process.  The desire is to proactively ensure that the right studies are done so that the best possible decisions result.  However, there isn’t always an absolute, clear decision to be made; resolution, therefore, requires a dynamic balancing of risks and benefits.  Questions need to be asked about whether certain subpopulations of patients may benefit from targeted use of a drug, or whether the safety concerns are sufficient to mean a more active withdrawal of a product from the market.   Advances in science and technology need to be better incorporated into the regulatory process, with a key area being safety science.   To continue to strengthen the science of regulatory safety, the need is to broaden not only the kinds of preclinical and clinical studies that can be done to deepen our understanding of safety, but also to broaden our understanding of how to apply and weight that data to further the science of risk management.

Source: Interview between Dr. Eli Adashi, Professor of Medical Science at Brown University and host of Medscape One-on-One, and Dr. Margaret Hamburg, Commissioner of the US Food and Drug Administration.  MedScape Today.

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Four proposals that address drug advertising and marketing issues, which have not been widely discussed, may be incorporated into the final health care reform bill.

1)  Of most concern to the pharmaceutical industry is a proposal to eliminate the tax deduction for drug advertising.  Direct-to-consumer (DTC) advertising is a prime target due to concern that DTC ads do not present an accurate picture of drug risks and benefits and that they drive use of new drugs before their safety is fully known.

2)  Health care reform bills in both the House and the Senate contain transparency provisions, akin to those in the Physicians Payments Sunshine Act of 2009, which propose for the disclosure of drug and device company payments to doctors to be federally mandated.

3)  Section 138 of the health care reform bill  bans the commercial use of “prescription information containing patient identifiable and prescriber identifiable data.”  If passed, Section 138 would end drug representatives’  current practice of tailoring their sales messages to each doctor’s prescribing history, which can put more pressure on doctors to prescribe newer, more expensive medications.

4)  The health care reform bill would authorize the FDA to evaluate whether use of a “drug facts box” format on drug labels – to more clearly present a drug’s benefits and risks – would improve health care decision making.  This  bill would also allow the FDA to set standards for comparative clinical effectiveness information to be included in drug labeling and advertising.

Source:  Health Reform Watch, 2 October 2009.

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Allergan, the maker of Botox, is suing the federal goverment by asserting that marketing restrictions prevent the company from communicating practical medical information — like patient selection criteria or optimal dosing patterns — to doctors that could reduce the risk of serious health problems arising from off-label uses of the drug.  Douglas S. Ingram, the executive vice president of Allergan, asserts that by allowing off-label drug use but by “prohibiting drug companies from proactively sharing relevant and truthful information with physicians regarding the risks, benefits, and techniques for off-label uses, does not serve the public health or patient care.”   Jeffrey N. Gibbs, a Washington lawyer specializing in food and drug law, asserts this case to be “the broadest attack on the constitutionality of FDA restrictions on speech brought by an individual drug company.  It’s a precedent-setting case.”   Although other pharmaceutical companies have not joined the lawsuit, the outcome will be closely monitored.  An article in the HealthLawProf blog attempts to place this issue into historical context.    It is speculated that Allergan may be utilizing the case to gain leverage with the Agency in negotiating the legal distribution of information on the prevalent off-label uses of drugs, like Botox.  New York Times, 2 October 2009.

What are your thoughts on how best can the pharmaceutical industry distribute safety information on the off-label use of its drugs?

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Enforced 15-day limit on FDA form 483 responses

Posted by cdavenport on Wednesday Oct 7, 2009 Under News Releases

Starting 15 September 2009, the FDA began enforcing a 15-day limit on post-inspection responses to an FDA-issued form 483  (Inspectional Observations).   Upon  completion of a facility inspection, the FDA may issue a form 483  to notify an inspected establishment’s top management of objectionable conditions.  These conditions may relate to products, processes, or other violations of the Federal Food, Drug, and Cosmetic Act (and related acts) that were observed during the inspection.  In the past, late and/or multiple responses to a FDA form 483 have delayed the issuance of warning letters while these responses were reviewed and addressed.  Under the current paradigm, however, ongoing or promised corrective actions may not preclude the issuance of a warning letter by the Agency.   The program’s goal is to optimize FDA’s already strained resources and to move firms to promptly correct noted violations.  The program will be assessed by the FDA after approximately 18 months.

Sources:  PharmTechTalk and Federal Register.

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