FDA looks to foster generics competition

In an effort to bring down the price of prescription drugs, the Food and Drug Administration’s new commissioner, Dr. Scott Gottlieb, has made increasing competition among generics manufacturers one of his top priorities. Gottlieb unveiled the Drug Competition action plan in late June. Ahead of a July 18 public meeting, the agency released a list of branded drugs that currently have no listed patents or exclusivities, and also have no generics.

The list came with a new policy to expedite review of applications for generics of products with limited competition. The FDA also has pledged to expedite the review of applications until a given product has three generic equivalents.

And with the goal of creating a guidance later this year on best practices for manufacturers on submitting abbreviated new drug applications — to be paired with an internal Manual of Policies and Procedures on how best to assess submitted ANDAs — the FDA held a public meeting on July 18, kicking off a two-month comment period during which stakeholders are encouraged to share their input on how best to improve generic competition and what current barriers exist.

Gottlieb has identified some of the barriers he sees to competition, which he said includes efforts by branded drug makers to slow generics development. Among the barriers he identified were making branded products unavailable for comparative testing, as well as restricting commercial contracts with distributors to make it difficult for intermediaries to sell to generics developers. He also pointed to the difficulty some companies have in accessing medications under limited distribution — either voluntary or through a Risk Evaluation and Mitigation Strategy.

CVS Health VP of policy and regulatory affairs Donald Dempsey, in his comments to the FDA on behalf of CVS Health, noted that the FDA could address the problem of REMS abuse by clarifying that FDA approval isn’t required for a generic maker to access samples from the manufacturer for the purpose of bioequivalence studies. Dempsey also said that finalizing a draft guidance from Decemeber 2014 stating an FDA letter wasn’t a legal requirement to access samples of a drug with an REMS would be a step forward.

“It is estimated by the Association for Accessible Medicine that misuse of REMS to prevent competition costs the healthcare system more than $5 billion every year,” Dempsey said. “While REMS are by law not supposed to restrict competition, the reality is that it is a common way for drug manufacturers to delay competitors.”

The Healthcare Supply Chain Association noted that one element its members see as a barrier is “pay for delay” practices, by which branded drug makers pay the maker of their first generic to wait before entering the market.

“This lack of competition delays patient access to cheaper alternatives. HSCA supports a legislative solution (S.124, Preserve Access to Affordable Generics Act) that would eliminate the tactics that allow brand-name manufacturers to prevent or delay generic manufacturers from entering the marketplace,” HCSA said.

HCSA also noted that the FDA’s backlog is an issue that delays the introduction of generics. At the public meeting, Gottlieb acknowledged that the process can sometimes take a while, highlighting that most ANDAs require four review cycles to reach approval.

In addition to the guidance on best practices aiming to remedy this, Gottlieb said that the second version of the Generic Drug User Fee Amendments, currently awaiting Congressional approval, contains a provision that would increase frequency and scope of FDA communication with applicants. It also would create a pre-ANDA program with a focus on complex generics, ensuring that applications for such medications are complete upon their initial submission. The goal, Gottlieb said, is to keep the FDA as the “gold standard” while working to keep prices low for consumers.

“These improvements will increase efficiency and output, [and] will also free up program staff to communicate more with applicants,” Gottlieb said. “It will also give us more time to engage in more strategic, value-added policy and scientific initiatives.”