Congress Must Ensure FDA Does Not Undermine the Affordable Care Act | Commentary

Posted September 22, 2014 at 1:32pm

Thirty years ago, Congress passed the Hatch-Waxman Act with bipartisan support. This legislation greatly expanded access to prescription drugs in America by accelerating the review process for generic drugs, thereby significantly lowering the cost to consumers, many of whom who are seniors and low- to moderate-income families. Since its passage, generic drugs now constitute approximately 84 percent of prescriptions in the United States.

The increasing cost of health care has most recently been addressed through the Affordable Care Act. It ensures access to biologic drugs, which treat some of the most debilitating of diseases from multiple sclerosis to cancer. Biosimilars are essentially generics of these complex drugs made from living cells. Prior to the passage of the ACA, there was no law that allowed these drugs to be available to the U.S. public.

The Food and Drug Administration is currently developing protocols to permit the marketing of biosimilars to patients in the United States. Toward this end, the role of the FDA should be to further expand quality health care at lower costs.

The cost of biologic drugs is currently 22 times more expensive than traditional drugs. This could range from $25,000 to $200,000 per patient, per year. It is projected that by 2020, biologic drugs could account for 75 percent of all U.S. drug spending. The increased reliance by patients on biologic drugs could clearly result in staggering co-pays and co-insurance costs.

The good news is the Congressional Budget Office has estimated that biosimilars could mean a 40 percent savings from brand-name counterparts. And biosimilars competition is not an untested concept. Europe has been benefitting from it since 2006. It is estimated that the influx of biosimilars on the European market has lowered costs there by as much as 40 percent.

Some of the producers of biologic drugs have advocated procedures that would weaken competition, thereby increasing profits at the expense of consumer savings. Despite the success of biosimilars in Europe and elsewhere, the makers of biologic drugs have advocated to the FDA to make it harder for biosimilars competition to flourish. The ACA provides 12 years of market exclusivity before biosimilars are allowed to compete. The argument offered to FDA by some producers is based on the assumption that additional layers of bureaucracy are necessary in order to appropriately name biosimiliars. Consumer advocates, pharmacists, labor and insurance organizations strongly counter that unique naming of biosimilars would actually result in confusion and medication errors. It is important to note that the Europeans have already rejected this approach.

I encourage the FDA to carefully consider this issue and its impact on America’s underserved population, as well as the new layers of bureaucracy which Congress opposed in the ACA. The agency could inadvertently derail competition from biosimilars, undermining a critical cost-saving tenant of the law.

Competition in the marketplace has consistently been a measure of how the public can access options by evaluating costs as well the quality of a product. It is clearly no less important when accessing our health care options, particularly when cost may be prohibitive.

It is rare that we have a chance to drastically improve access to lifesaving drugs. We brought better care and lowered costs back in 1984 with Hatch-Waxman. In 2014, the FDA has the chance to make President Barack Obama and Congress’ goal of saving patients and the government billions of dollars a reality.

Members of Congress should continue to fight to ensure access to biosimliar drugs, which would help to deliver health care at an affordable cost.

Ron Dellums served as a Democratic congressman from California’s 9th District from 1971 to 1998 and was a founder of the Congressional Black Caucus. He previously served on the Presidential Advisory Council on HIV/AIDS and is currently the co-chairman of the Health Disparities Working Group.