FDA faces allegations over ‘capricious’ allergy drug approval
Endo and its subsidiary have challenged the FDA's approval of an application by BPI Labs and Belcher Pharmaceuticals | Dispute argues the FDA undermined regulatory frameworks and patent protection.
Endo and its subsidiary have filed a complaint against the US Food and Drug Administration, challenging its decision to grant final approval of an application relating to an allergic reaction drug.
The suit, filed in the US District Court for the District of Columbia, was aimed at Xavier Becerra, the secretary of health and human services, Robert Califf, the commissioner of food and drugs, and the FDA, disputing BPI Labs and Belcher Pharmaceuticals application.
Endo, and its subsidiary Par Pharmaceutical, argued the FDA's approval was arbitrary, capricious, and unlawful, as it was issued despite a statutory 30-month stay preventing such approval and claimed that the approval infringed on their patents and violated regulatory procedures.
Par Sterile, a subsidiary of Par Pharmaceutical, received FDA approval in 2012 for its new drug application (NDA) covering the single-dose Adrenalin (epinephrine) product.
Adrenalin treats severe allergic reactions and can also be used for sudden asthma attacks, or during cardiac arrest.
Subsequently, in 2013, the company received approval for another version of Adrenalin. These approvals became the first FDA-approved epinephrine injection product available in the US, according to the suit.
Par Pharmaceutical claimed to have invested substantially in research and development to enhance its Adrenalin product, obtaining multiple patents covering the reformulated versions.
Alleged patent bypassing sparks suit
Endo and Par Pharmaceutical's complaint concerned the FDA's handling of BPI's supplement application for a multi-dose vial presentation of injectable epinephrine.
Despite Par's patents being listed by the FDA, BPI referenced only one of Par's products, not the one considered to be its pharmaceutical equivalent.
By doing so, BPI allegedly avoided submitting extensive safety and efficacy data to the FDA, claimed Par.
The FDA's regulation ‘deviation’
Despite an ongoing dispute over BPI’s product, the FDA granted final approval to BPI's supplement.
Par alleged that neither BPI nor the FDA informed it of this approval until it discovered BPI's product listed for sale in a database.
In response, Par reached out to both BPI and the FDA, questioning the legality of the approval and requesting a reversal, the suit said.
While the FDA initially imposed an administrative stay to reconsider the matter, it later rescinded the stay, prompting Par to file its most recent complaint.
Endo and Par argue the FDA’s decision violated the statutory requirements and undermined the intent of the Hatch-Waxman Act.
The suit stated that BPI’s application, which allegedly referenced a different NDA not included in its original application, should have triggered a 30-month stay.
The pair argued that FDA's approval of the supplemental application without this stay deprives them of important statutory benefits, including protection against premature market entry and potential economic losses.
They also argued the decision deviates from established practice and allows applications to avoid the statutory framework and gain unfair advantages in the market.
Endo and Par sought judicial intervention, an emergency and preliminary injunction to stay the FDA's approval of BPI's supplement, a cancellation of the approval, and for it to be subject to the 30-month stay provision.
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