Clinton, Sanders Release Prescription Drug Policy Proposals

The two frontrunners for the Democratic presidential nomination, Hillary Clinton and Sen. Bernie Sanders of Vermont, released prescription drug policy proposals last week that would cut prices and end “pay-for-delay” deals.

Clinton and Sanders propose allowing Medicare to directly negotiate drug and biologic prices with drugmakers. They also suggest rebates for low-income Medicare beneficiaries, importing drugs from abroad, as long as safety standards meet those in the U.S., prohibiting “pay-for-delay” deals that keep generics off the market and requiring drug pricing and research cost transparency.

Clinton’s plan would cap out-of-pocket costs for prescription drugs and eliminate corporate tax write-offs for direct-to-consumer advertising and require the funds be invested into research and development.

Going forward, the plan calls for mandatory FDA pre-clearance procedures for direct-to-consumer ads funded through user-fees paid by pharmaceutical manufacturers.

The plan would require that companies benefitting from federal support for drug projects invest that funding in research and not in marketing or greater profits. It also calls for increasing competition for specialty drugs including biologics. Biosimilars should be given prioritized, expedited review in markets that have only one or two drug products that drive up costs.

Additionally she calls for lowering the biologic exclusivity period from 12 years to seven to spur competition and funding the FDA’s Office of Generic Drugs to clear the generic drug approval backlog.

The candidates’ plans came a day after Turing Pharmaceuticals received nationwide scorn after the company instituted a 5,000 percent price hike for Daraprim, a drug critical to patients with lowered immune systems and the only one indicated to treat a specific parasitic infection.

Sanders proposes terminating exclusivity from a drugmaker convicted of criminal violations such as off-label promotion, kickbacks, anti-monopoly practices and Medicare fraud. He says that even though the Justice Department has won lawsuits requiring millions of dollars in restitution, drugmakers treat those fines as the cost of doing business.

Industry groups were quick to speak out against Clinton’s proposal, with the Biotechnology Industry Organization saying it would hinder companies’ ability to develop new therapies and result in fewer medicines produced. Additionally, patient access would be limited if the government set prices and became involved in private sector R&D, BIO president and CEO Jim Greenwood said.

The Pharmaceutical Research and Manufacturers of America echoed this sentiment, adding that importation of medicines from abroad risks patient safety with no evidence of savings. The group also said Clinton’s plan would result in higher costs and fewer coverage options for seniors on Medicare. — Kellen Owings