It’s impossible to predict how the PDUFA issue will play out this year. But the House bill 1561 has a number of interesting provisions. It was introduced last week by Henry Waxman and Edward Markey, two California Democrats and longtime critics of the pharmaceutical industry.

The bill is, of course, one of many possible starting points for a new approach to drug safety. It’s premature to get alarmed. But the legislation is interesting nonetheless, as it would institute stiff penalties for companies failing to complete post-marketing studies. That’s new.

How would fines be calculated? For drugs that have been on the market for a year, the damage would be $50,000 per violation plus “10 percent of the annual United States sales revenue during the year prior to which the person is subject to the civil penalty, based upon data from IMS Health Inc.‘s Retail and Provider Prospective Combined Purchases on the United States sales revenue of the drug.”

In a nod to the recent IOM report on drug safety, Waxman and Markey propose a two-year period in which a newly approved drug would be tagged with “a unique symbol indicating the newly approved status of the drug or indication.”

Federal Database Expansion

The bill would require an online registry much like www.clinicaltrials.gov, except with more onerous reporting requirements for industry. An example: “a general description of the clinical trial and results, including a description of and the reasons for any changes in the clinical trial design that occurred since the date of submission of clinical trial information for inclusion in the registry database established under paragraph (2) and a description of any significant safety information.”

Adding clinical trial results is a major departure from the current data deposited in clinicaltrials.gov. Aside from opposition to that provision within the industry, the medical journal publishers will quietly squash that idea before it gets too big. Journal editors want a monopoly on doling out trial results.

Walking the Critical Path

The bill would also create a federal institute to pursue the agency’s Critical Path agenda. The oddly named “Reagan-Udall Institute for Applied Biomedical Research” would, according to the proposed legislation, study biomarkers, animal models, pharmacogenomics, computer modeling, toxicology and “the development of data analysis technology and methodology for use in device, biologic, drug, and diagnostic development ... [and] advancing improvements to the design and conduct of clinical trials.” The bill says it would be located near the District of Columbia, which is not exactly the favorite location of the Udall or Reagan families.

It’s hard to disagree that the industry and the regulators would benefit from more funding or scientific knowledge about Critical Path topics. There’s just one problem. Congress already created something similar, the C-Path Institute.