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Monday, June 10, 2024 | Back issues
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Judge Gutters Drug-Exclusivity Challenge

WASHINGTON (CN) - A drugmaker lost its challenge to the regulatory limbo that waylays the exclusivity to which new pharmaceuticals are entitled, though Congress may soon modify these laws.

Japan-based Eisai Inc. had filed a petition with the Food and Drug Administration back in July 2013, complaining about how the agency calculated the exclusivity periods for two of its new drugs, Belviq and Fycompa.

Because both Belviq and Fycompa contain controlled substances, their marketing approval required scheduling decisions by the Drug Enforcement Administration.

The FDA had approved both of Eisai's new drugs in 2012, but the DEA's scheduling process kept the products off the market for nearly a year longer.

Although the DEA did eventually sign off on both Belviq and Fycompa, Eisai argued that the FDA improperly let its five years' of exclusivity begin running before it had the green light to market the products.

Indeed when the FDA sent Eisai letters after approving both drugs, it made clear that the labels on the products would need further revisions pending the completion of DEA scheduling under the Controlled Substances Act.

Eisai said this qualified it for an exception in the FDA's rules, and that the date of the FDA approval letters cannot be considered the triggering date for market exclusivity.

Eisai turned to the U.S. District Court in Washington when the FDA denied its petition last year, but U.S. District Judge Randolph Moss granted the agency summary judgment last week.

"This case turns on the meaning, not the wisdom, of an FDA regulation implementing the Hatch-Waxman Amendments," the Sept. 30 decision states.

Passed in 1984 to amend the Federal Food, Drug, and Cosmetic Act, Hatch-Waxman was designed to encourage the manufacture of generic drugs and established the modern system of government generic drug regulation.

Though the exclusivity regulation does provide for an exception under limited circumstances, Moss said "the FDA has interpreted that exception narrowly, and the court is bound to defer to the agency's reasonable interpretation of its own regulation."

Moss thus focused on the narrow question of whether "the FDA's interpretation of the exception to its 'date of approval' regulation 'plainly erroneous or inconsistent with the regulation?'"

Siding with the agency, Moss called it reasonable for the FDA to construe "the exception to mean that the requirement for further FDA approval must appear in the letter itself."

The FDA's letters to Eisai included no language regarding the need for additional approval, the court found.

Eisai did not return a request for comment on the ruling and has not publicly stated if they will appeal the decision.

Moss has not been alone this year in considering exclusivity windows. This past March, the U.S. House of Representatives passed a bill called the Improving Regulatory Transparency for New Medical Therapies Act, which would start the clock on marketing exclusivity after the date of DEA scheduling, rather than after the FDA's approval of new drugs.

The new bill would also amend the Controlled Substances Act to require the DEA schedule a drug no later than 90 days after the FDA approves it.

With the Senate Health, Education, Labor, and Pensions Committee having just passed the bill Wednesday, it now heads to the full Senate for discussion and a possible vote.

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