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    FDA calls out 39 drug companies for allegedly blocking access to generics

    The Food & Drug Administration (FDA) campus in Silver Spring, Md.
    Andrew Harnik/Associated Press/File
    The Food & Drug Administration (FDA) campus in Silver Spring, Md.

    Johnson Johnson’s Actelion Pharmaceuticals, Celgene, and Gilead Life Sciences are all potentially blocking generic drug makers from accessing samples of their products, along with three dozen other drug companies — according to new data out Thursday from the FDA intended to publicly shame them for what it calls “gaming tactics.”

    The new list, which also includes Cambridge-based Biogen and Shire PLC of Lexington, is part of the Trump administration’s efforts to lower prescription drug prices that kicked off with a presidential address Friday. While broader regulatory and legislative changes must go through a complex and often lengthy process, top health officials have used their bully pulpits this week to call out a number of companies for what they consider bad behavior.

    Thursday’s announcement from the FDA focuses on branded companies that may be trying to delay competition from a generic competitor by blocking access to product samples the other company needs to test its own version of the drug — “gaming tactics,” as FDA Commissioner Scott Gottlieb said Thursday. Generic companies need somewhere between 1,000 and 5,000 doses of a drug to complete the studies that prove their product is equivalent with the branded one.


    The FDA said it’s gotten more than 150 inquiries from generic companies that want help getting access to a branded drug maker’s samples. The new information on the agency’s website breaks down which companies and which drugs were the subject of those inquiries and how many inquiries the agency’s received for a given product. (A handful of the companies on the list are generic manufacturers who make a product for which there is no brand-name drug, meaning the generic product counts as the “reference” product, in FDA lingo.)

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    In 21 cases, the generic company has asked the FDA to take the extra step of sending a letter to the branded company on its behalf, stating clearly that certain other FDA restrictions shouldn’t get in the way of distributing samples. Those are also disclosed.

    Celgene has had 13 complaints about its practices related to its cancer drug Revlimid, and gotten four letters. It’s had another 10 complaints associated with a leprosy and multiple myeloma product, Thalomid, about which FDA has sent two letters, and another eight related to another cancer drug, Pomalyst. Actelion, which Johnson Johnson acquired in 2017, has had 14 complaints about its hypertension drug Tracleer alone, and received five letters from the FDA about it. It had another eight complaints about another hypertension drug, Opsumit. Gilead’s had 10 complaints about its own hypertension product, Letairis, and gotten two letters. No other products have gotten complaints in the double digits.

    “We’re taking these steps today because we believe greater transparency will help reduce unnecessary hurdles to generic drug development and approval,” Gottlieb said.

    Branded companies often base their decisions to restrict access based on what they say are limitations imposed by a so-called limited distribution program or the equally arcane Risk Evaluation and Mitigation Strategy (REMS) program, which is meant to balance the risks and benefits of a given drug. Some of the products in the new list are indeed subject to those program limits — but some aren’t at all, the FDA said. Even when they are, the agency wants generic companies to have access.


    “I want to be very clear: A path to securing samples of brand drugs for the purpose of generic drug development should always be available,” Gottlieb said. “Even in the case of limited distribution programs such as those required by certain REMS, there should be a path forward for generic drug development.”

    The FDA is planning to update the lists semi-annually.

    Gottlieb also said FDA is notifying the Federal Trade Commission about the inquiries, and encouraged generic companies to raise the cases with that agency, which polices anticompetitive behavior in the pharmaceutical industry.

    Generic drug makers, along with a broader coalition of insurers, pharmacy benefit managers, and other groups, have been pressing Congress to pass legislation that would take a bigger bite out of the problem than mere public shaming. That legislation, known as the CREATES Act, would give generic drug makers a way to sue over these “gaming tactics.” Though it has bipartisan support in both chambers of Congress, it has largely stalled in the face of opposition from pharmaceutical industry lobbyists.

    A spokesman for PhRMA, the main trade association for drug makers, said the group is concerned that the FDA’s Thursday release “lacks proper context,” and “conflates” different scenarios.


    “It is important to differentiate between those products for which FDA has received complaints as opposed to those products for which it has received a request for a safety determination letter,” he said via email. “Additional context is essential and we believe the Agency should give innovator companies the opportunity to submit their appropriately redacted response to the recipient of a safety determination letter.”

    The spokesman also said the agency should post additional information, like how long it took a review a given company’s defense or the number of requests granted and denied.