Senate Bill Seeks to Improve Access to Affordable Rx Drugs

A bill called the “Improving Access to Affordable Prescription Drugs Act” (S771) was introduced on March 29, 2017, by Senator Al Franken of Minnesota and 15 co-sponsoring Democrats to improve the Affordable Care Act by bringing down the skyrocketing prices of prescription drugs, which the Senators state is one of the main reasons why healthcare costs are rising.

The bill seeks to tackle prescription drug costs by increasing transparency and accountability, boosting access and affordability of key drugs, spurring innovation, and increasing choice and competition. A companion bill [H 1776] with the same name was introduced in the House of Representatives by Rep. Jan Schakowsky of Illinois and 4 co-sponsoring Democrats.

The bill notes “much of the biomedical innovation motivating new drug discovery is supported by the National Institutes of Health (NIH) and other federal programs.” To better understand how research and development costs, manufacturing and marketing costs, acquisitions, federal investments, revenues and sales, and other factors influence drug prices, the bill requires drug makers to disclose this information, by product, to the secretary of the HHS, who in turn will make it publicly available.

The bill will examine how patient assistance programs affect drug prices and “the extent to which drug makers are using independent charity assistance programs to drive up profits.” It also allows the secretary of HHS to negotiate with drug companies to lower prescription drug prices for Medicare, which it is not currently allowed to do. HHS can only negotiate drug prices for Medicaid and the Department of Veterans Affairs.

In addition, the bill will do the following:

• Task the HHS Office of the Inspector General to “monitor changes in drug prices and take steps to prevent drug makers from engaging in price gouging”
• Close the Medicare Part D coverage gap
• Allow wholesalers, licensed US pharmacies, and individuals to import qualifying prescription drugs made at FDA-inspected facilities from licensed Canadian sellers, and in 2 years, from countries that meet standards comparable to US standards
• Create a $2 billion prize fund at the National Institutes of Health (NIH) to fund entities that develop superior antibiotics to treat serious and life-threatening bacterial infections and to fund research that advances such treatments and is made publicly available
• Create a center for clinical research within NIH to conduct all stages of clinical trials on drugs that may address an existing or emerging health need and provide $10 billion in funding over 10 years
• Make it illegal for brand-name and generic drugs makers to enter into anti-competitive agreements in which the brand-name drug maker pays the generic drug maker “to keep more affordable generics off the market”
• Require that products awarded 3-year New Clinical Investigation Exclusivity must show significant clinical benefit over existing therapies manufactured by drug applicants in the 5-year period preceding the submission of the application.