User Fees, Drug Safety - Pharmaceutical Technology

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User Fees, Drug Safety
Top Priorities for FDA


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Manufacturers propose a delay in posting new safety signals until FDA and the sponsor agree that the problem is related to a specific drug and what the appropriate response might be. Releasing safety information before it is fully evaluated, commented attorney John Kamp, could undermine FDA's "golden reputation" for issuing reliable, science-based assessments on a drug's safety and efficacy.

In addition to confusing consumers and exposing manufacturers to additional liability charges, FDA's Drug Watch proposal calls for the agency to issue patient information sheets for all approved drugs, even those without emerging safety issues; FDA also would develop professional information sheets on all new molecular entities. Pharmacists and physicians, as well as manufacturers, are cool to this idea. At the FDA meeting, Joe Cranston of the American Medical Association (Chicago, Il, http://www.ama-assn.org/) termed patient information sheets redundant and confusing for doctors, and advised FDA to consult more with medical specialty societies on developing useful communications tools on drug risk. Nicholas Ratto of First DataBank (San Bruno, CA, http://www.firstdatabank.com/) said that FDA patient information tools duplicate private sector consumer medical information that is easier for patients to understand.

Despite, or perhaps because of, this multiplication of warnings and advisories, it's hard to find risk information about a specific drug on FDA's Web site. Consumers don't know that most drug safety information appears on the CDER Web page. In another year or so, the Daily Med Web site from the National Library of Medicine (Bethesda, MD, http://www.nlm.nih.gov/) should contain all current drug labels and could provide a central portal to additional risk information. The current FDA Web site is frustrating even experts who use it regularly.

Protection against pandemics

Even though FDA is struggling with its expanding workload and drug safety concerns, it faces additional assignments that require even more resources. One prominent challenge is to ensure access to vaccines and treatments to protect the nation against looming epidemics and bioterrorism threats. The Bush administration unveiled a $7.1-billion Pandemic Influenza Plan this past November that includes a $2.8-billion crash program to revitalize vaccine manufacturing in the United States. The aim is to support a shift from egg-based flu vaccine production to advanced cell-culture approaches able to produce a new flu vaccine in six months. Another $1.5 billion would buy 40 million vaccine doses by 2009, plus $1 billion to stockpile enough antivirals such as Roche's (Basel, Switzerland, http://www.roche.com/) "Tamiflu" (oseltamivir) and GlaxoSmith-Kline's (Middlesex, UK, http://www.gsk.com/) "Relenza" (zanamivir) to treat 25% of the population.

Congress approved a down-payment on the program in December by adding $3.8 billion for pandemic preparedness to the $453-billion 2006 defense appropriation bill. Although that amount is approximately half of what the administration asked for, it provides initial support for efforts to expand domestic vaccine production and to build up stockpiles. The legislation also provides $20 million to support FDA research and oversight of vaccine production, a relatively paltry amount that primarily will be spent on resource-intensive inspections of vaccine manufacturing facilities in the United States and abroad. The 2004 flu vaccine crisis required FDA officials to spend weeks monitoring vaccine quality and inspecting manufacturing sites, while also engineering accelerated approval for new sources of supply. A huge ramp-up of stockpiles will tax FDA's ability to monitor drug stability, although growing demand for flu treatments will require close scrutiny for counterfeit products.


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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
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