Gottlieb Outlines New Efforts on Biosimilars, OTC Drugs and Opioids
FDA will soon unveil a comprehensive plan to promote more competition and availability of biosimilars, according to commissioner Scott Gottlieb. During a 2/6 address to the Alliance for a Stronger FDA, Gottlieb expressed the agency’s dissatisfaction with how its biosimilars program has progressed and its small impact on the pricing of such products entering the market. He said the biosimilars competition plan will be similar to the agency’s Drug Competition Action Plan for traditional generic drugs that he rolled out after coming on board last year.
“There are things we can do from a regulatory standpoint to try to better facilitate the creation of this (biosimilars) market,” he told the Alliance gathering. “A lot of issues relate to the supply chain and payer community. If we really want a vibrant market for biosimilars, then health plans have to be willing to demonstrate there is a market for these products, and not just go with the incumbent product because of high rebates or because the incumbent player is willing to discount to a level to exclude the biosimilar.”
Addressing biosimilar issues is part of FDA’s role in helping to keep drug costs down, which is a top Trump Administration goal. Without FDA actions, Gottlieb said, biosimilar developers will soon recognize there is no viable way to enter the market and biosimilar investment could dry up. “We need to think holistically about how we address what essentially is a new market,” he said. From a regulatory standpoint, he said, there are options where FDA can act to “facilitate the development of new biosimilars, such as claims of interchangeability, which can help promote uptick.”
On generic drug competition, Gottlieb said there are more guidances in development to help. One will address issues around the Hatch Waxman Act to modernize the agency’s interpretation of the law. Another guidance will address drug-device combination products and how to bypass Hatch Waxman issues when the device component may exclude a generic entry due to patented features, Gottlieb said. “We need to be more creative with how we interpret Hatch Waxman to facilitate more generic products,” he said. Additionally, internal discussions have targeted how branded companies are gaming the system and more will be said on this in the future.
Gottlieb’s address also mentioned over-the-counter (OTC) drug modernization. He said FDA is working with the Alliance and others on a legislative proposal to modernize the framework for OTC drug availability, including a proposed regulation called “ENSURE” that would allow more modern tools to be used at point of pharmacy, such as medical apps that can allow patients to self select for certain OTC drugs. “So you can envision a statin where one might input a cholesterol level to obtain a certification to get an OTC statin,” he said.
On opioid addiction, Gottlieb said the agency’s next steps will include efforts to reduce exposure and thus new addictions, 50% of which are traced to medical settings. Next week, he said, FDA officials will be discussing how to begin a process of requiring blister packaging for immediate-release (IR) formulations of opioid drugs. “If the IR formulations were more commonly available in packs that comported with clinical use guidelines for what appropriate dispensing should be — three-day, seven-day, 14-day and probably not 30-day — then more doctors would reflexively write (prescriptions) for those packs and then lower overall exposure would be achieved.” He said questions remain on whether FDA can mandate this or whether it must work voluntarily with the supply chain and manufacturers to achieve this.