Friends of Cancer Research presents the following special cancer policy alert on an issue of importance to the cancer and medical research communities.

Senators Kennedy and Enzi Introduce Drug Safety Bill
Legislation aims to strengthen regulatory authority over new products without compromising patient access

Yesterday, February 1, 2007, the Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Michael B. Enzi (R-WY) and Chair Edward M. Kennedy (D-MA) introduced a Bill (S.484), entitled, “The Enhancing Drug Safety and Innovation Act of 2007.” While acknowledging that all drugs have risks associated with their use, this legislation is mainly focused on creating a framework for planning of how new drug sponsors and FDA will identify, assess and manage risks associated with product use. Senators Enzi and Kennedy feel that the result would be both a more efficient and effective way to obtain safety information, without restricting access. They introduced a similar bill in the 109th Congress.

S.484 Bill Summary

Divided into four titles, this legislation aims to strengthen current FDA regulatory authority over new products without compromising patient access.

> Risk Evaluation and Mitigation Strategies

It calls for the creation of risk evaluation and mitigation strategies (REMS) for the approval of drugs and biologics and new indications for these products. REMS are designed to be integrated, flexible mechanisms to acquire and adapt to new safety information about a drug.

> Reagan-Udall Institute for Applied Biomedical Research

The legislation also calls for the creation of a public- private partnership—the Reagan-Udall Institute for Applied Biomedical Research. This institute would spur innovation, advance the FDA’s Critical Path Initiative to modernize medicine, and improve the sciences of developing, manufacturing, and evaluating the safety and effectiveness of drugs, devices, biologics and diagnostics.

> Clinical Trial Registry and Clinical Trial Results Database

Moreover, the bill would establish a publicly available database at the National Institutes of Health to enhance patient enrollment in clinical trials of drugs for any disease or condition and provide a mechanism to track subsequent progress of trials. This clinical trials database could possibly build upon the existing clinicaltrials.gov, or be establish as a separate database. An additional component would include the results of all clinical trials, so that patients and providers have the most up-to-date information regarding novel uses and new products.

> Conflict of Interest and FDA Advisory Committees

The bill would also make refinements to FDA’s process for screening advisory committee members for financial conflicts of interest, with new guidance on how FDA should evaluate advisory board candidates and disclose potential conflicts. This title also calls for an annual report by FDA describing the status of Advisory Committees and number of individual vacancies.

Bill Revisions

This bill was first introduced last year to the 109th Congress (S.3807). Changes in the reintroduced version include clarifications to the potential elements of a REMS – including the potential use of large healthcare networks as a data source. The revised bill also contains a new calculation paradigm for an additional appropriated resources needed to implement the programs based upon adjustments for the added workload. Revisions also address the governance of the Regan-Udall Institute to model it after the NIH and CDC Foundations, as well as the procedures for reporting members disqualified from serving on Advisory Committees.

Next Steps

Senators Charles Grassley (R-IA) and Christopher Dodd (D-CT) introduced a bill this past week addressing drug safety issues, as well. This bill (S.468) is focused upon the surveillance of drugs once they are marketed through the establishment of the Center for Postmarket Evaluation and Research for Drugs and Biologics.

The debate on the Senators Enzi and Kennedy’s bill will likely be rolled into the larger drug safety deliberations with several public meetings and Congressional hearings planned for late February and March. During this time period, policy makers will also consider proposed drug safety enhancements included in the Prescription Drug User Fee Act <http://www.fda.gov/bbs/topics/NEWS/ 2007/NEW01544.html>, new programs recently announced by FDA to address drug safety recommendations, as well as other legislation and recommendations that has or may be introduced.

It currently appears that the Senate HELP Committee plans to move at least five FDA-related pieces of legislation together as one package: PDUFA, Kennedy-Enzi Drug Safety bill, Best Pharmaceutical for Children Act, Pediatric Research Equity Act, and Medical Device User Fee Act.

Friends of Cancer Research has been working with leading research advocates, patient groups and expert academic clinicians in order to provide the greater biomedical research community’s perspective and recommendations on issues designed to strengthen the FDA. These topics are of great importance to improving drug safety, ensuring access, and promoting innovation that will directly impact patient health.

For further information please contact Jeff Allen at jallen@focr.org

 

### 

Over the past ten years, Friends of Cancer Research (Friends), a 501 (c)(3) non-profit, has pioneered innovative public-private partnerships, organized critical policy forums, educated the public, and brought together key communities to develop collaborative strategies in the field of cancer research.  Through these efforts, Friends continues its mission in raising awareness on the importance of cancer research to accelerate the progress toward better tools for the prevention, detection, and treatment of all cancers.