- Speed the FDA's drug approval process: Congress should require the FDA to prioritize review of generic drug applications when there are three or fewer manufacturers in the market, and ensure decisions for these applications are made within 240 calendar days, as stipulated in the "Making Pharmaceutical Markets More Competitive Act."
- Prohibit manufacturers from misusing the Risk Evaluation and Mitigation Strategy (REMS) to limit competition: Manufacturers have used the FDA's REMS program to create restrictive distribution networks that deny generic drug makers access to samples for bioequivalence studies, which are required for the drug approval process. Congress should stop these anticompetitive practices by prohibiting manufacturers from restricting access to covered products, as called for in the CREATES Act.
- Eliminate pay-for-delay deals: Some branded manufacturers sidestep competition by offering to pay generic companies to delay or scuttle plans to bring lower-cost alternatives to market. These anticompetitive deals cost consumers and taxpayers an estimated $3.5 billion in additional drug costs every year, according to the Federal Trade Commission, and should be outlawed by Congress, as called for in the Preserve Access to Affordable Generics Act.
- Ensuring access to biosimilars: The ability to safely substitute biosimilars for innovative biologics will be critical to competition. FDA guidance should clearly explain that applications demonstrating the same clinical results as the reference product are interchangeable and granted biosimilarity status. In addition, the guidance should allow applicants to conduct interchangeability studies using products obtained from any market, rather than limiting these studies to U.S. licensed products that often cost much more than those from other countries.
- Prevent abuses of orphan drug status: Orphan drug status creates incentives for manufacturers to develop drugs that assist in the treatment, diagnosis or prevention of rare conditions. However, the designation is abused when companies apply for and win orphan drug status, only to expand its use to other indications. Congress should consider limiting orphan status to new drugs, and prohibit the designation in cases where there is a reasonable likelihood the drugs will be used beyond the orphan population.
- Crack down on product evergreening: To extend the life of a patent, some manufacturers seek new drug approval for a changed formulation of the original, such as an extended release or changed dosage version. Once approved, the original drug is pulled from the market, leaving no opportunity to obtain samples for bioequivalence testing. This practice should be barred, and Congress should study the evergreening practice to determine whether regulatory or legislative changes are needed to continue to advance generic drug competition.
- Prevent abuse of Citizens Petitions: Manufacturers seeking to block generic entry can file frivolous citizens petitions, contributing to the FDA's application backlog and delaying market entry by months. According to an analysis, brand manufacturers, not consumer groups, were behind 92 percent of all citizens petitions, and 90 percent of them were rejected. To help address this problem, petitions should be required to be filed by the principles, not front groups or consultants that mask identity. Further, frivolous petitions should be subject to financial penalties that disincent this anticompetitive behavior.
- Ensuring safe, decades-old drugs are still available to consumers at reasonable prices: The FDA has launched initiatives to encourage formal approvals for older, grandfathered products. As part of this process, the FDA requires competing manufacturers to exit the market once a New Drug Application (NDA) is approved. When these manufacturers leave the market, providers have experienced significant price increases due to the lack of competition. FDA should allow other manufactures 18 to 24 months to exit the market after announcing the approval of an NDA.
- Generic drug labeling: Under current law, brand and generic versions of a drug are required to carry the same labeling. However, the FDA has proposed a new rule that would change this requirement by making both brand and generic makers responsible for their own labeling. This will create different labels for equivalent products, resulting in confusion that could undermine generic prescribing. Instead, the FDA should be responsible for reviewing all safety information and serving as the central authority for uniform labeling.
About Premier Inc.Premier Inc. (NASDAQ: PINC) is a leading healthcare improvement company, uniting an alliance of approximately 3,750 U.S. hospitals and more than 130,000 other provider organizations. With integrated data and analytics, collaboratives, supply chain solutions, and advisory and other services, Premier enables better care and outcomes at a lower cost. Premier, a Malcolm Baldrige National Quality Award recipient, plays a critical role in the rapidly evolving healthcare industry, collaborating with members to co-develop long-term innovations that reinvent and improve the way care is delivered to patients nationwide. Headquartered in Charlotte, N.C., Premier is passionate about transforming American healthcare. Please visit Premier's news and investor sites on www.premierinc.com for more information about the company.