Your Rx kinda high? Senator Brown thinks so

Senator Sherrod Brown to Linda Meinelt, February 1, 2011

Dear Mrs. Meinelt:

I am working to lower drug prices and increase the timely availability of generic biologic drugs in the market.. Biologic drugs, derived from proteins, treat diseases and conditions such as cancer, Multiple Sclerosis, and rheumatoid arthritis. Biologics are an expensive subset of prescription medicines, often ranging in price from $10,000 to $100,000 per patient, per year. Like chemical drugs, generic versions of biologics would bring competition to the pharmaceutical marketplace and reduce costs for patients, as well as state and federal governments. Access to safe and effective — but less expensive — versions of brand-name biologics is clearly in the public interest.

Americans spent more than $40 billion in 2007 on biologic drugs, and this number is expected to increase since biologic drugs represent a larger and larger segment of our pharmaceutical marketplace. I am committed to bringing down the costs of biologic drugs by increasing the availability of generic alternatives to these expensive medicines

Last week, I became an original cosponsor of bipartisan legislation, S.. 27, the Preserve Access to Affordable Generics Act. S. 27 would increase competition in the pharmaceutical market by stopping anticompetitive agreements between brand name and generic drug manufacturers that delay the availability of generic drugs for patients. S. 27 would end “pay-for-delay” settlements. The practice of “pay-for-delay” allows brand-name drug manufactures to pay a generic drug competitor to delay its entry into the market in order to further increase profits for the brand-name company. This legislation would allow the Federal Trade Commission (FTC) to take action against companies participating in “pay-for-delay” agreements, thus increasing generic biologics and reducing costs for consumers .

Additionally, I led a bipartisan letter to the Food and Drug Administration (FDA) Commissioner, expressing concern about possible misinterpretations of current law that could further delay the availability of generic biologic drugs. My letter to Commissioner Hamburg clarified that the Biologics Price Competition and Innovation Act (BPCIA) — which was included in the Patient Protection and Affordable Care Act — allows the FDA to review generic applications in a more timely manner. Though I strongly oppose the 12-year monopoly period granted to brand-name biologics — shielding them from generic competition — it is imperative that the FDA resist efforts that would further delay access beyond the 12-years granted in law. The FDA has been pressured to interpret the law in ways which would extend the exclusivity well beyond 12 years, which was not the intent of BPCIA and is not in the best interest of patients.

I am committed to lowering prescription drugs costs through increasing market competition and generic options. Absent generic competition, biologic drugs will continue to cost patients thousands of dollars for a single dose. I strenuously object to any efforts that would further block or delay generic competition at the expense of patients in need.

Sincerely,
Sherrod Brown
United States Senator