FDA Issues Draft Guidance to Foster Competitive Access for Bioequivalence Studies

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The guidance seeks to help generic and biosimilar drug sponsors gain access to reference products from brand-name manufacturers.

FDA has issued a guidance document that details how generic-drug makers can obtain product samples from brand-name drug manufacturers for product testing. The guidance, titled “How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protocols Contain Safety Protections Comparable to Applicable REMS for RLD,” comes on the heels of criticisms that FDA does not help facilitate competition among manufacturers.

Generic and biosimilar manufacturers have complained that brand-name manufacturers use the Risk Evaluation and Mitigation Strategies (REMS) program improperly, preventing generic-drug manufacturers from obtaining drug samples for testing in comparability studies. While REMS plans typically ensure that the benefits of a drug or biological product outweigh its risks, some drug makers say brand-name manufacturers use REMS programs (and their distribution restrictions) as an excuse not to share products. This refusal to share supplies of products results in fewer competitors in the marketplace, a recent report by PCMA argued

To facilitate prospective generic-drug manufacturers’ access to reference-listed drugs (RLD), FDA says in the guidance it will issue letters to the RLD sponsor. Provided the generic-drug applicant’s bioequivalence study protocol contains the proper safety protections, the letter will state that providing “sufficient quantity of the RLD to the interested generic firm or its agent to allow the firm to preform the testing necessary to support its ANDA [abbreviated new drug application]” would not violate REMS.

Congressmen Steve Stivers (R-OH) and Peter Welch (D-VT) recently introduced a bill protecting the interests of generic-drug makers in the US House of Representatives. This act, known as the “Fair Access for Safe and Timely (FAST) Generics Act of 2014,” says that current FDA practices are not “sufficient to prevent anticompetitive practices that interfere with access to reference products which is necessary for the timely development of affordable generic drugs and biosimilars.” According to the bill, should noncompliance by a license holder occur, a generic-product developer may sue for “injunctive relief and treble damages.”


The Generic Pharmaceutical Association (GPhA) already commented on the move by FDA, saying that it commended FDA’s efforts to ensure timely access for medicines. In a statement, the organization cited findings from Matrix Global Advisors, which assert that abuse of REMS programs costs the American health system and its patients $5.4 billion a year. "GPhA applauds FDA for taking helpful steps to address, and hopefully limit, scenarios in which some brand drug companies misuse Risk Evaluation and Mitigation Strategies (REMS) programs to thwart competition from more affordable generic drugs," said Ralph G. Neas, president and CEO, GPhA.

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