Tuesday, July 29, 2014
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Mass. recieves $960,000 from ineffective drug manufacturers

Massachusetts will receive about $1 million in settlement payments to resolve illegal drug marketing allegations against a Texas-based pharmaceutical company.

The settlement, reached in December, is a $48 million agreement to be paid to 47 states by Healthpoint Ltd. and DFB Pharmaceuticals, Inc. after allegations arose that they illegally charged MassHealth and other state health care and Medicaid programs for Xenaderm, an ineffective drug marketed to treat bed and pressure sores, according to a press release Friday from Mass. Attorney Gen. Martha Coakley.

“Illegal drug marketing imposes unnecessary costs on the Medicaid system and taxpayers that are footing the bill,” Coakley said in the release. “This settlement demonstrates the importance of policing the pharmaceutical industry and remaining vigilant with respect to drug marketing misconduct.”

Healthpoint and DFB will pay more than $666,000 plus interest to MassHealth, and more than $329,000 to Massachusetts Medicaid program, according to the release.

Healthpoint had submitted false statements about Xenaderm in order to acquire Medicaid and Medicare money, according to the complaint filed by the U. S. Department of Justice in April 2011.

Stephen King, public affairs specialist for the Food and Drug Administration, said in an email that the FDA found the active ingredient in Xenaderm ineffective in the 1970s.

“While products containing Xenaderm’s principal active ingredient, trypsin, were on the market prior to 1962, the FDA had determined in the 1970s that trypsin was less-than-effective for its intended use,” he said.

Chris Gill, a professor at the School of Public Health at Boston University,  said approving a new drug is a long process.

“For a drug to be approved by the FDA it has to be both safe and efficacious, and it has to be pure,” Gill said.

In the case of Xenaderm, Gill said that there was probably no physical danger.

“What we have here is something that’s probably safe and unadulterated, but not efficacious,” Gill said. “It’s not going to hurt anybody. It’s just spending a lot of money on something that’s not going to help anyone.”

Gill said some drugs are useful to treat things other than the FDA approved purpose, and there is nothing wrong with that practice.

“Clinicians are entirely entitled to prescribe a drug for an off-label purpose,” he said. “But, the company is not allowed to market that. Drugs get used in ways that aren’t in accordance with the labels all of the time”

If a company does market an off-label purpose, the FDA gets involved and they send out warning letters to pharmaceutical companies who have been marketing their drugs in different ways than what was approved by the FDA, said Judith Barr, professor at the Northeastern School of Pharmacy.

However Barr said the practice of sending out letters is not effective

“It could be a little more aggressive,” she said. “There are so many ways to get off-label use of medications into the medical community.”

Barr said increased funding to the FDA has allowed some progress to be made.

“There is more surveillance within the FDA for the limits to which — especially direct to consumer ads — companies are allowed to go, and they are being held to the FDA’s initial indication for uses,” Barr said. “But, it’s not where it should be. Not yet.”

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