FDA to Speed Reviews of More Generic Drugs, Offers Lists of Those With No Competition

Regulatory NewsRegulatory News | 27 June 2017 |  By 

The US Food and Drug Administration (FDA) took major steps toward increasing generic drug competition on Tuesday by releasing a list of off-patent pharmaceuticals with limited or no competition, and by prioritizing the review of abbreviated new drug applications (ANDAs) for which there are fewer than three ANDAs approved for the reference listed drug.

Both moves seek to increase generic drug competition and lower the cost of pharmaceuticals in the US. The generic drug industry group, known as the Association of Accessible Medicines, praised the move alongside other industry experts. The shift follows the release of an amendment attached to the Senate user fee reauthorization bill that would have made a similar change to the prioritization of generics.

And for an FDA commissioner once criticized for his close ties to industry, Scott Gottlieb has now taken steps to directly address US drug prices that none of his predecessors took. In fact, the agency has previously tried to avoid the politics of pharmaceutical pricing and stick to matters concerning the efficacy and safety of drugs.

Gottlieb said in a statement Tuesday: “No patient should be priced out of the medicines they need, and as an agency dedicated to promoting public health, we must do our part to help patients get access to the treatments they require.”

Guido Rasi, executive director of the European Medicines Agency, last week told attendees of DIA’s annual conference in Chicago that he wanted to keep the decision of pricing separate from the agency’s assessments of benefits and risks.

Priority Reviews

In an update to the agency’s Manual of Policies and Procedures (MAPP) on the prioritization of the review of ANDAs, FDA says: “Generic products for which there are fewer than three ANDAs approved for the reference listed drug (RLD) and for which there are no blocking patents or exclusivities on the RLD may receive expedited review.”

Last week, FDA also issued draft guidance for sponsors on how they can qualify for these reviews that are two months shorter than other reviews of ANDAs.

The update builds on the MAPP’s most recent update from March 2016, when FDA said it would prioritize ANDAs when there is only one competitor. Other generics that can receive priority reviews include:

  • Potential first generic products for which there are no blocking patents or exclusivities on the reference listed drug;
  • ANDAs related to drug shortages;
  • ANDA submissions subject to special review programs, such as the President’s Emergency Plan for AIDS relief;
  • ANDAs related to public health emergencies;
  • Submissions related to certain government purchasing or procurement activities, including expiration-date extensions or packaging changes usually requested by the Government-Wide Quality Assurance Program;
  • Submissions subject to statutory mandates or other legal requirements; and
  • Supplements for which expedited review is requested under 21 CFR 314.70(b)(4).

Lists of Generics Lacking Competition

FDA also on Tuesday released two lists of drugs, each of which contain more than 100 active ingredients, including one “for which FDA could immediately accept an ANDA without prior discussion,” and the second for drugs “involving potential legal, regulatory, or scientific issues which should be addressed with the Agency prior to submission of an ANDA.”

The first list includes some drugs that made headlines because their prices have spiked in recent years, like Turing Pharmaceuticals' toxoplasmosis treatment Daraprim (pyrimethamine) and Valeant Pharmaceuticals' Wison's disease treatment Cuprimine (penicillamine). Others listed include J&J subsidiary Actelion Pharmaceuticals' pulmonary artery hypertension drug Tracleer (bosentan) and two Bristol-Myers Squibb chemotherapies: Lysodren (mitotane) and Vumon (teniposide).

The second list includes the epilepsy treatment Peganone (ethotoin), first approved by FDA in 1957, the leprosy treatment no longer available in the US, known as Lamprene (clofazimine), which was first approved by FDA in 1986, Eisai's ovarian cancer treatment Hexalen (altretamine), which first won FDA approval in 1990, AbbVie's respiratory distress syndrome treatment for infants Survanta (beractant), which first won approval in 1991 and Endo Pharmaceuticals' cancer treatment Valstar (valrubicin), first approved in 1998.

The lists of active ingredients that lack generic competition will be updated every six months, FDA says.

“We intend to develop it into a list of individual NDA drug products that lack competition,” FDA adds, noting that new drugs approved in the last year have been excluded.

On 18 July, FDA will also hold a public meeting to discuss finding a balance between encouraging innovation in drug development and accelerating the availability to the public of lower cost generics. 

List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic

Prioritization of the Review of Original ANDAs, Amendments, and Supplements

FDA Tackles Drug Competition to Improve Patient Access


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