ADHD drug maker suing DEA over ‘effectively shutting down’ manufacturing

ADHD drug maker suing DEA over ‘effectively shutting down’ manufacturing

OMAHA, Neb. (WOWT) – During an ongoing national shortage for drugs used to treat attention-deficit-hyperactivity disorder (ADHD), one manufacturer is suing the federal government.

A New York-based law firm representing Ascent Pharmaceuticals, Inc. said the Drug Enforcement Administration is keeping its client from manufacturing generic prescriptions to treat ADHD.

“At the very time that there is a federal government-recognized scarcity of ADHD medications, the government has elected to effectively shut down the company that was making 20 percent of the generic forms,” said Jim Walden, managing partner at Walden, Macht and Haran.

Walden said the DEA’s basis for the move is over alleged record-keeping violations by Ascent—assertions Walden said are wrong.

Hanging in the balance was Ascent’s application for a production quota.

“They were supposed to decide Ascent’s quota for manufacturing in July of ‘22,” Walden said. “Over the course of the last year-and-a-half, DEA has been conducting this audit of Ascent’s record keeping, and Ascent has cooperated. It provided all the documents when DEA expressed some concerns about documents.”

He said over that year-and-a-half, Ascent had been falling back on its stockpile of raw materials for making ADHD drugs, but that it has since run out.

He said the DEA finally denied Ascent’s quota application only after the company asked a judge to speed up the agency’s decision on it in late September.

“We had been strung along, believing that we were going to get approved any day. After we filed that lawsuit, DEA filed its final denial two days after.”

So Walden has filed an emergency motion to restore Ascent’s ADHD drug manufacturing.

This comes during a time when prescriptions used to treat ADHD have been in short supply, which local pharmacies have been feeling.

It started with Adderall, then expanded to other medications like Focalin, Ritalin, Concerta, and Vyvanse.

Because of that, Walden said it’s a bad time for the government to put a muzzle on Ascent Pharmaceuticals’ manufacturing efforts.

“It used to make roughly 47 million pills that were used for ADHD treatments,” he said. By August of this year, it was only producing about 100,000 of them. Now, it’s producing none.”

6 News reached out to the DEA for comment but has not heard back.

The agency has said pharmaceutical companies have more than enough raw ingredients to make ADHD drugs.

Walden said he wouldn’t be surprised if the U.S. Court of Appeals for the Second Circuit makes a decision on Ascent’s lawsuit in the next couple of weeks.

42 USC 1395: Prohibition against any Federal interference


§1395. Prohibition against any Federal interference

Nothing in this sub chapter shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person.

(Aug. 14, 1935, ch. 531, title XVIII, §1801, as added Pub. L. 89–97, title I, §102(a), July 30, 1965, 79 Stat. 291 .)

One Response

  1. Why that just surprises the hell out of me. Just to think the CDC and the DEA might stick their noses in where they don’t belong? Why that is just outrages they would try and mislead the long acting guidance that has been working so much better than the crap they have just forced on us!!!!!!!!!!!!

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