User Fees, Drug Safety - Pharmaceutical Technology

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User Fees, Drug Safety
Top Priorities for FDA

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The most controversial provision in the defense funding bill—and one of critical importance for industry—provides liability protection for manufacturers of pandemic countermeasures. The legislation protects companies from liability suits, but applies only to vaccines and drugs administered during a public health emergency and for a specified disease. Democrats attacked the provision as excessively broad because its protections extend to gross negligence and reckless misconduct, but BIO termed the bill balanced and important for rebuilding the nation's vaccine infrastructure. At the same time, the legislation fails to provide additional patent incentives for new product development. Strong opposition from generics makers blocked adoption of a controversial wild card exclusivity provision that would have allowed manufacturers to gain a patent extension on a commercial product in exchange for producing a low-profit countermeasure.

Meanwhile, FDA is working to assemble the extensive resources needed for evaluating new production strategies and investigational vaccine lots, as well as assess new antivirals, diagnostic tests, and devices needed to combat a public health emergency. These efforts will be managed by an FDA Rapid Response Team, which will coordinate agency pandemic preparedness activities with industry, the Centers for Disease Control and Prevention (Atlanta, GA,, and the National Institutes of Health. The aim is to detect and deal with production roadblocks to ensure an adequate supply of antivirals and vaccines in case of a disease outbreak. Among other things, the team has authority to allow other firms to manufacture a patented product under emergency use authorization.

Although every bird that catches avian flu has been making headlines, many scientists are skeptical that a pandemic will emerge in the United States in the near future. Policy makers are recalling the 1976 swine flu debacle, when the government wasted billions developing vaccines for a flu pandemic that never materialized. If the current plan succeeds in modernizing and expanding the US vaccine production infrastructure, that may be money well spent. But manufacturers will share the blame if they benefit from government grants but never have to respond to a real emergency.

Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634,


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