Brookings issues recommendations for generic drug competition as PDUFA VI expiration looms
While the FDA, industry insiders and politicians have all weighed in on what the newest iteration of PDUFA should look like, a new report from a private research group outlines an opportunity to change some of the FDA’s authority to promote generic entry.
The Brookings Institution’s Rachel Sachs, Marta Wosińska, Richard G. Frank, and Loren Adler partnered with USC’s Leonard D. Schaffer Center for Health Policy & Economics to author a paper published Tuesday to address some concerns within FDA’s current regulatory processes. They specifically refined three measures to promote better generic drug competition: the Citizen Petition mechanism; the approval of “complex generic drugs;” and generic drug “parking” under the Hatch-Waxman Act.
Citizen petitions, in which the FDA allows petitioners to ask the agency to either reject or delay new drugs on grounds that review is “necessary to protect the public health,” can be useful, according to the authors. However, the authors said that evidence suggests not-so-benign motives.
Evidence suggests that interested parties (who are largely, though not exclusively, branded pharmaceutical firms facing the loss of market exclusivity) are often filing citizen petitions that have the effect of delaying generic or biosimilar entry to defer competition and maintain their existing market position.
Their proposed solutions? “Strengthen the FDA’s authority to dismiss petitions and penalize non-meritorious filers by instituting time limits and associated penalties,” and “improve the transparency of the FDA’s review of citizen petitions by requiring the agency to report more details about delays and the agency’s review process.”
The second FDA authority the authors looked at was “complex generics,” which refers to small molecule nonbiological drugs that have difficulty establishing bioequivalence. One issue facing complex generics includes FDA guidance on drug-device combinations, also known as the “sameness standard” and transparency.
According to the group, the FDA could “relax the sameness standard from substantial equivalence to functional equivalence” on drug-device combinations and streamline the review of ingredient sameness for injectable complex generics. They also pointed to potential legislative options in which the FDA could further clarify certain aspects.
The third and final issue addressed was generic drug parking, the practice where companies who are the first to get to the FDA with a generic candidate pause at the tentative approval stage. The authors said that while some reasons for “parking” the product can be justified, they offered some suggestions to improve and incentivize more timely generic entry.
The first thing the authors suggested was to amend provisions surrounding the existing, 180-day exclusivity reward for patent challenges — and change it “to specify a presumption that any patent litigation settlement between generic and brand firms that do not allow for immediate generic entry be viewed as grounds for forfeiture of the generic’s 180-day exclusivity period.”
The authors added that this type of authority could discourage more obscured forms of remuneration from brand to generic firms (including MFEs and allowances to sell in foreign markets) and encourage first-filing generic firms to enter because delaying entry will risk losing the benefit of exclusivity.
Secondly, the suggest creating additional financial incentives to encourage “at-risk launching” by the first generic filer, adding that a possibility would include having the Government Accountability Office (GAO) examine its options. Those could include granting additional exclusivity to generic drugs that launch at-risk under certain conditions and their potential effects.
Another solution to generic drug parking was introduced to Congress as the BLOCKING Act three years ago, which was criticized by two ex-HHS attorneys a few weeks ago.
The bill was originally written to provide a workaround to generic drug “parking.” In short, the bill would allow the FDA to approve generic drugs from rival competitors who were not the first before the agency if certain conditions were met, such as:
- A subsequent Paragraph IV ANDA is ready for final approval but for a first applicant’s eligibility for 180- day exclusivity;
- At least 30 months have passed since the first applicant submitted its ANDA to FDA;
- The 30-month patent litigation stay of ANDA approval invoked when patent infringement litigation is timely initiated does not preclude approval of a first applicant’s ANDA; and
- FDA has not approved a first applicant’s ANDA as of the date the first three requirements above are met.
Social image: Brookings Institution via Brookings Institution website