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.
PERSONALIZED MEDICINE AND COMPARATIVE RESEARCH
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
PRICES AND PATHWAYS
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
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, firstname.lastname@example.org