Washington Report: The Pendulum Swings - Pharmaceutical Executive

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Washington Report: The Pendulum Swings
FDA cracks down on safety. Haven't we been here before?


Pharmaceutical Executive


Guidance To further demonstrate that it has policies and programs to ensure drug safety, FDA issued three final guidances in March designed to improve the collection of data on drug safety prior to approval, to enhance adverse event tracking, and to ensure the safe use of medications. A main theme of these documents, plus a separate Good Review Management Guidance, is to encourage more consistent review practices and approval policies across drug review divisions. The guidances ( http://www.fda.gov/cder/guidance/) address:

Premarket risk assessment The guidance outlines testing approaches likely to enhance a sponsor's understanding of product safety concerns, noting the need for longer and larger trials for drugs intended for long-term use.

RiskMAPs The guidance emphasizes that only a limited number of high-risk products will warrant the use of a Risk Minimization Action Plan (RiskMAP) to educate patients. This reflects concerns of doctors and pharmacists about dealing with too many special prescribing and dispensing programs.

Pharmacovigilance The guidance discusses ways in which pharma companies can establish good pharmacovigilance programs for marketed drugs. In identifying strategies for identifying and analyzing safety signals, FDA recommends that manufacturers also investigate signs of confusion about a product's name, labeling, packaging, or use.

In addition to Congressional hearings, drug safety is the prime topic at a number of public meetings on policies affecting FDA and drug marketers. The Institute of Medicine Committee on Identifying and Preventing Medical Errors discussed drug safety reporting systems at its April meeting. At the same time, FDA's Science Board devoted much of its April session to pre- and post-marketing safety programs for drugs and biologics.

Also last month, scientists from industry, academia, NIH, and FDA discussed a guidance on how pharma and biotech companies may submit pharmacogenomic data to FDA (see "A Push for Personalized Medicine," page 28). FDA acting deputy director Janet Woodcock opened the meeting by outlining the "real imperative" for improving the current wasteful and uninformative system for testing drug candidates, and shifting to research methods that use biomarkers to predict drug side effects and benefits. Success in this area can address the current crisis over affordability and access, she said, as well as the need for a more agile process to produce medical countermeasures in response to public health emergencies.

Perhaps in the end, the public will have a better understanding of the dangers associated with all pharmaceuticals and how virtually impossible it is to guarantee a risk-free medical treatment.

Jill Wechsler is Pharmaceutical Executive's Washington correspondent.


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