United States: USFDA Publishes A List Of Drug Makers Who Are Delaying Generic Competition

On May 17, 2018, USFDA Commissioner Scott Gottlieb issued a statement saying, "no patients should be priced out of medicines they need to support their health. As stressed by the President and Secretary Azar last week, one of the Administration's highest priorities is advancing policies that increase competition as a way to help make drugs more affordable and improve access".

He also said that "there isn't one single action that's going to solve this issue. We will achieve these public health goals through the coordinated effort of different federal agencies working in partnership with industry and other stakeholders. Among these efforts, we are especially focused on addressing tactics we sometimes hear of branded companies pursuing as a way to forestall expected generic entry".

One of the stalling tactics is when potential generic applicants are prevented from obtaining samples of certain brand products necessary to support approval of a generic drug. The inability of generic companies to purchase the samples they need slows down, or entirely impedes, the generic drug development process – leading to delays in bringing affordable generic alternatives to patients in need.

USFDA has received numerous inquiries from prospective generic applicants indicating interest to develop a generic version of a marketed drug but are unable to obtain the necessary samples of the reference listed drug (RLD) – typically referred to as the brand drug – because the RLD is subject to limited distribution. The USFDA received inquiries on drugs that are under Risk Evaluation and Mitigation Strategy (REMS) and those that are not-

  • Risk Evaluation and Mitigation Strategy (REMS) - A REMS is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication. While all medications have labelling that informs health care stakeholders about medication risks, only a few medications require a REMS with elements to assure safe use (ETASU).
  • In other cases, the brand companies have placed restrictions in their commercial contracts or agreements with prescription drug distributors, wholesalers or specialty pharmacies that limit the ability of these intermediaries in the drug supply chain to sell samples to generic drug developers for testing.

USFDA, to address this issue of RLD access and to provide transparency regarding these inquiries, has released a list of companies that have potentially been blocking access to the samples of their branded products. The list identifying all drug products for which FDA has received an RLD access inquiry related to limited distribution of the marketed RLD, with details regarding the RLD sponsor, the drug product, and the number of inquiries is as follows:

In the above list a total of 52 reference listed drugs (RLDs) have been described, whereas, roughly half of RLD comes under REMS with Elements to Assure Safe Use (ETASU), but it doesn't mean that generic companies would not get these RLD samples for testing. In this regard, USFDA developed a process for informing the RLD sponsor in writing that FDA will not consider providing the RLD for these purposes to be a violation of the REMS.

According to it, upon request from a prospective generic applicant, FDA reviews their bioequivalence study protocols to assess whether they contain safety protections comparable to those in the applicable REMS for the RLD. If FDA determines that they do, they (FDA) notify the prospective generic applicant of this determination by letter. The prospective generic applicant can then request that FDA send a second, separate letter (the Safety Determination Letter) directly to the RLD sponsor stating that FDA will not consider providing product to the particular generic applicant to be a violation of the REMS for the RLD.

In the list, in cases where there is no such REMS program in place, the FDA informs the generic drug developer that there are no FDA-required restrictions on the distribution of the drug that would impede obtaining samples. They also notify the same to the Federal Trade Commission (FTC), the agency responsible for addressing anticompetitive business practices about these inquiries.

Conclusion:

The USFDA's actions to make RDL accessible to generic companies is a way to bring more competition to the prescription drug market, to make drugs more affordable and more accessible.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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