Issues and Opportunities Challenge Biotech Manufacturers - Demand for new vaccines and therapies in 2010 will be offset by concerns about drug prices and product safety. - BioPharm International


Issues and Opportunities Challenge Biotech Manufacturers
Demand for new vaccines and therapies in 2010 will be offset by concerns about drug prices and product safety.

BioPharm International
Volume 23, Issue 1


The Sentinel System requires access to electronic health information systems, a prominent goal of health reform efforts. Medical record databases offer a way to accelerate detection of drug adverse events and to streamline data collection from clinical trials and population studies.

At the same time, broader access to personal health information has generated demands for stronger protections against unauthorized disclosure of patient records, which may stymie research and treatment.


Health information systems also are critical for the development of personalized, or individualized, medicine and the diagnostics needed to determine who may benefit or experience harm from certain therapies. The shift to more targeted treatment requires access to personal health data to recruit research subjects who meet increasingly specific genetic-based enrollment criteria, and to identify those individuals who should—or should not—receive a treatment based on specific genotype.

Researchers also will be tapping health system databases to assess outcomes and to compare the risks and benefits of medical products. Federal agencies are funding a number of comparative effectiveness research (CER) projects with an eye to assessing a broad range of medical treatments and strategies. The industry seeks limits on federal funding of studies that compare one drug to another and focus on cost comparisons, but more CER will inevitably highlight comparative prices as well as health benefits.


Whatever the outcome of health reform legislation, the high prices of many biotech therapies will remain in the spotlight. Both Wall Street analysts and patient advocates have documented record increases in wholesale drug prices this past year, at a time when inflation was declining. The studies exposed manufacturers to charges of jacking up revenues in anticipation of tighter legislative controls on pharmacy spending.

Such developments will continue to build support for greater access to generic drugs, including follow-on biologics (FOBs). Congress is poised to establish a regulatory pathway for bringing biosimilars to market. There is general agreement among generics makers and innovator firms on FDA regulatory standards and clinical testing requirements, but strong disagreement on patent issues: pharmaceutical and biotech companies successfully pushed for 12-years exclusivity on FOBs which has infuriated generics makers. Manufacturers on all sides will be assessing how these requirements will shape the development of biosimilar products.


Transparency is a recurrent theme in health reform and regulatory matters. Efforts to lower the prices of biomedical treatments have built support for broader disclosure of manufacturer rebates and discounts negotiated by payers and health plans. Congress seeks to further shed light on industry payments to physicians as a way to reduce commercial influence on prescribers.

Manufacturers also face more transparency in FDA regulatory decisions and pending drug applications. Commissioner Margaret Hamburg established a high-level FDA transparency task force last June to identify ways to better inform the public about FDA operations. The panel headed by Deputy Commissioner Joshua Sharfstein is examining the viability of disclosing information about applications filed with the agency, what kind of emerging safety information should be disclosed and when, and whether early communication about ongoing safety reviews of foods and medical products would be beneficial or raise unnecessary concerns about a product. The panel will issue a report in the coming year on what information the FDA should be able to release on its own and what changes require new regulations or legislation.

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

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