Regulatory Beat: Multiple Issues Challenge Biotech Industry in 2007 - The need to reauthorize PDUFA will focus attention on product safety, prices, and a host of regulatory issues - BioPharm


Regulatory Beat: Multiple Issues Challenge Biotech Industry in 2007
The need to reauthorize PDUFA will focus attention on product safety, prices, and a host of regulatory issues

BioPharm International
Volume 20, Issue 1

Over the past year, FDA has been busy forming consortia to implement many of the 76 opportunity projects that could yield new tools for evaluating test therapies, streamlining clinical trials, and modernizing manufacturing methods.

FDA also is encouraging a shift to personalized medicine, based on pharmacogenomics data available to identify those individuals most likely to respond to a medicine or to experience serious side effects. Several consortia seek to validate new biomarkers and develop diagnostics and screening tests that can identify certain enzymes and receptors linked to response. FDA is encouraging broader use of pharmacogenomic data by offering manufacturers early informal advice on how to analyze and submit genomic data that can facilitate regulatory review. Scientists from FDA and industry seek to develop standards for submitting and validating such information.


Both biomedical innovation and product safety stand to benefit from a number of FDA e-data initiatives. A new bioinformatics board headed by deputy commissioner Janet Woodcock is overseeing the development of data and technology standards, including a standard computerized medical vocabulary. Priorities are to overhaul the agency's adverse-event reporting system and to establish an electronic system for listing drug products and manufacturing sites.

These efforts build on FDA's requirement that pharma companies file drug labeling information electronically, beginning with newly approved drugs and those filing efficacy supplements. The rule also revises the content and format of the package insert to provide the most important information about prescription drugs up front where it can be easily accessed by health professionals as well as patients. These data are establishing an electronic prescribing information database, operated by the National Library of Medicine and readily available to the health community.


FDA will continue to play a critical role in efforts to guard against terrorist events and emerging health threats. The agency is facilitating development and approval of new countermeasures for anthrax, plague, radiation emergencies, and infectious diseases, while also ensuring the quality of vaccines and treatments for seasonal and pandemic influenza. Such high-profile assignments not surprisingly draw outside scrutiny: the HHS Inspector General is examining FDA's progress in assessing and inspecting vaccine manufacturing processes and new vaccine production technologies.


Campaigning Democrats called for lower drug prices and improved access to needed therapies, largely by repealing Medicare's "noninterference" clause. Changes are easier to promise than to implement though, and they raise the specter of price controls.

Although pharma and biotech companies may be more enthusiastic about the Democrats' promise to expand federal support for more stem cell research, added support for biomedical research won't do much good if attacks on prices and practices dry up financial investment in the biotech industry, says Greenwood of BIO. "We need to persuade the new leadership that when they're making speeches on stem cell research, they have to make sure that biotech companies will be there to develop the promised new cures," Greenwood says. "We need to protect the biotech goose laying the golden eggs."

Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD 20815, 301.656.4634,

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