Advocacy Proposal

Millions of American families face the looming cloud of rising pharmaceutical drug prices that overshadow the benefits of treatment each year. The price of prescription drugs for terminal illnesses is in large a contributing factor to medical expenses that often leads to bankruptcy. Due to the Food and Drug Administration (FDA) and Center for Medicare/Medicaid Services’s (CMS) lack of regulation over pharmaceutical drug prices, the corporations who market and sell the biomedical drugs make enormous profits through price spiking while their consumers are left scrambling to pay for them. Although the daunting problem exists on a large scale, there are several solutions that can be implemented to prevent future generations from facing the same issues.

The United States House of Representatives’ Bill 3513, the Prescription Drug Affordability Act of 2015, suggests CMS and FDA intervention in the regulating of prescription drug affordability. It states that all drugs covered under Medicare Part D, which includes all inpatient treatments and some outpatient treatments, through drug price negotiations with drug manufacturers, closure of the gap in covered versus not-covered medication, prescription drug rebates, and importation of drugs that are cheaper abroad. It was introduced on September 16,2015 in the House of Representatives by Representative Elijah Cummings of Maryland and on September 10, 2015 in the Senate by Senator Bernie Sanders of Vermont. The bill has not been voted on yet in either the House of Representatives or in the Senate.

The United States House of Representative introduced Bill 1455, the Speeding Access to Already Approved Pharmaceuticals Act of 2015 on March 18, 2015. It’s sponsored by Representative Steve Stivers of Ohio. The bill amends the Federal Food, Drug, and Cosmetic Act to require the FDA to facilitate the development and expedite the process of a “new drug, or the device has been approved in the European Union.”

The Mayo Clinic Proceedings Journal, published a patient-driven initiative and petition to lower the cost of drugs—particularly cancer drugs.—written and compiled by many authors such as Dr. Ayalew Tefferi. These scholars suggest that creating a post-FDA drug approval review would propose a fair price for new treatments, based on the value to patients and health care. They also suggest allowing a body such as Medicare to negotiate drug prices, so all other insurance companies following Medicare’s lead will enforce the same policies and their prices and co-pays may decrease as well.

The United States House of Representatives Bill 3513 in conjunction with the Mayo Clinic Proceedings will create a comprehensive protection against pharmaceutical companies’ astronomical prices and greed. They cover the basis of international drug equivalents and their importation, negotiations of prices, and FDA review processes in terms of changing the way this country approaches drug treatment programs and paying for them. These policy recommendations encompass preventing delay of generic drugs, patent system reform, increasing competition for medications, as well as enforcing price negotiations with Big Pharma.

Thesis: The enforcement of preventing delay of generic drugs, patent system reform, increasing competition for medications, as well as enforcing price negotiations by the FDA and CMS with Big Pharma can address the movement of change in this nation surrounding at least one aspect of the repercussions of highly priced healthcare.