‘Medical Food’ Firm Says FDA Blocks Lupus Drug

TRENTON, N.J. (CN) - A supplement manufacturer claims in court that the Food and Drug Administration ignored used terrorizing tactics to prevent the firm from marketing a product for women with lupus as "medical food."

The complaint filed Monday by Morristown, N.J.-based Health Science Funding is the second-such lawsuit the company has filed against the FDA over the product, which it claims helps prevent breast cancer in women with lupus.

Health Science Funding's product, "Prastera" contains the hormone dehydropiandrosterone, or DHEA, which is widely sold as a dietary supplement.

By the company's own admission, DHEA supplements do not do much for most people, as excess amounts are merely excreted in urine. But for female lupus sufferers, HSF claims, the supplements restores DHEA levels to normal, thereby cutting slashing the risk of breast cancer by half and "the risk of death from any cause" by almost 80 percent. Many women with lupus die from cancer, kidney failure, or suicide.

The company says Prastera is safer than other versions of DHEA and can help female patients with lupus, but that the FDA has conducted a campaign of terror against the supplement maker in order to keep Prastera off the market.

The FDA's seizure threats and multiple warning letters are "specifically designed to produce an in terrorem effect, and appear specifically designed to frustrate judicial review," the complaint says.

In this respect, the new litigation is similar to Health Science Funding's prior suit against the FDA; filed in 2013, it was ultimately settled out of court.

In both suits, Health Science Funding alleges that its Prastera supplement meets every federal benchmark for being labeled a "medical food": it is designed to be taken perpetually by a patient under a doctor's supervision, and it is intended for a particular disease.

Further, the lawsuit argues that the FDA should not make the call as to whether Prastera is necessary for managing lupus.

"FDA does not (and cannot) make patient medical evaluations; doctors do," the complaint says. "And patient medical evaluations are confidential medical records. FDA thus does not (and cannot) require patients or doctors to submit them to FDA for review."

Health Science Funding says its product has "a far greater benefit than many drugs" and questions "why in the world lupus patients do not take DHEA dietary supplements."

The FDA has so far rebuffed the company's attempts to label its supplements as medical food, saying it is not aware of any "distinctive nutritional requirements" for lupus management, the complaint says.

According to court documents, Health Science Funding and the FDA reached an informal settlement of the company's original lawsuit after a behind-closed-doors meeting with the judge hearing the case.

Health Science Funding said it agreed to stay its action, and the government agreed to back down.

In June, however, two FDA inspectors visited the company's offices, and the agency has since said it plans to seize the company's Prastera gels.

"We think money is the driving factor" behind the FDA's renewed objections, said Mark Pohl, the company's attorney, during an interview with Courthouse News.

He noted that medical food manufacturers are not required to pay any fees, whereas drugs require an initial $1.4 million filing fee, and then yearly establishment fees that can cost more than $2 million.

An FDA spokeswoman declined to comment on the lawsuit.

Follow @NickRummell

Subscribe to Closing Arguments

Sign up for new weekly newsletter Closing Arguments to get the latest about ongoing trials, major litigation and hot cases and rulings in courthouses around the U.S. and the world.

Email *

Submit