Gottlieb Tells More on on Generic Drug Policy Relief
FDA commissioner Scott Gottlieb has outlined new approaches the agency will implement to help speed up generic drug reviews and approvals. Speaking at a 7/19 meeting on Hatch-Waxman Amendments and whether appropriate balance is still maintained between brand and generic companies since the law was enacted in 1984, Gottlieb said it is important to make sure FDA’s regulatory requirements are “efficient, predictable, and science-based,” and that competition is encouraged.
By the end of the year, Gottlieb said the agency will issue two key documents to streamline the ANDA review program. First, a “Good ANDA Assessment Practices” policy will “outline ways that we intend to streamline the ANDA review process inside FDA by, among other things, eliminating unnecessary, duplicative procedures and greatly increasing the efficiency of our review,” he said. It will build on the knowledge gained from the user fee program — for example, the practice of “truncating” reviews prevents applicants from fixing their submissions and getting them approved. “The result is additional review cycles, not faster approval,” he said.
The goal of the policy, according to Gottlieb, “is to help make sure we work smarter. The primary ANDA assessment should focus on ‘need to know’ regulatory requirements. Supervisors should validate, not re-do, the assessment. The level of supervisory scrutiny should vary according to the experience level of the primary reviewer and the risk and complexity of the product. At the end of the review cycle, if the ANDA is not approved, the complete response letter should clearly say what needs to be fixed. If the written communication is unclear, FDA should follow up and explain it over the phone in a direct, scientist-to-scientist exchange.”
The second document will aim to improve submission quality. “It will set forth common, recurring deficiencies that we see in applications, and provide advice on how these problems can be avoided in the first place, so applicants can send us ANDAs that are ‘right the first time,’” Gottlieb told the meeting.
He expressed concern about companies gaming the system to delay generics entering the market. He said the agency is currently “looking for places where this sort of gaming is happening, and we will change our rules where we can, to make sure the competition that Congress envisioned is taking place.” He said the agency is considering a public shaming campaign against branded companies who block generic companies from obtaining drug samples to conduct necessary bioequivalence testing by arguing that an FDA-mandated risk evaluation and mitigation strategy (REMS) program prevents their release.
Over the past few years, generic companies have been allowed to request that FDA send a letter to a branded manufacturer indicating that the purchase of samples for such purposes is permissible. “One of the things we’re considering is whether to make these letters from FDA publicly available, to make more widely known the instances where generic drug makers may be having trouble getting access to branded drugs,” Gottlieb said. “These letters could contain important information that can help inform broader discussions about access and competition. Their public release could be one step to help ensure that unnecessary hurdles to generic drug development are removed.”
During the meeting’s comment period, Pharmaceutical Research and Manufacturers of America vice president David Korn said that “REMS are not upsetting the balance” and that contended legislation is not warranted because FDA has sufficient authority in this area. He said FDA needs to finalize its draft guidance allowing generic companies to request letters from FDA about obtaining samples to close “important scientific, regulatory, and legal questions.”
Association for Accessible Medicines (formerly Generic Pharmaceutical Association) CEO Chip Davis said: “It is abundantly clear that the refusal to provide samples is about one thing and one thing only – preventing competition. In 2012, the Senate passed legislation that would have ended such abuses, but successful lobbying by the branded industry prevented enactment... But there is a limit to what FDA can do on its own. Congress should also take immediate action by passing the CREATES Act and the FAST Generics Act, bipartisan legislation in the House and Senate, to prevent the misuse of REMS and restricted distribution schemes to delay generic drug competition. The cost of failure is significant, and will only encourage anti-competitive practices to grow. A recent study estimated that the potential market for products subject to REMS or restricted distribution was worth more than $20 billion.”