After years of litigation involving three different federal lawsuits, Pamlab LLC, a prescription medical foods maker based in Covington, reached a settlement to remove “imposter products” from the market.

Keith Daigle, Pamlab general counsel, said the details of the settlement were confidential.

“I can tell you that the lawsuits have been dismissed, the counterclaims have been dismissed. All three (imposter products makers) have agreed to notify major wholesalers – customers of theirs – that their products have been withdrawn from the market,” Daigle said.

The companies – Acella Pharmaceuticals, Seton Pharmaceuticals and Trigon Pharmaceuticals – have also notified the three compendium databases, which house the listings for brand products and their substitutes, that their products are no longer available, Daigle said.

Medical foods are dietary supplements that help patients manage diseases related to nutritional deficiencies. Medical foods’ active ingredient or ingredients must be found in a natural food source, according to Pamlab, but the dose amount is administered at a level higher than possible through normal diet.

Unlike prescription drugs, prescription medical foods do not have to undergo testing and approval by the U.S. Food and Drug Administration. 

Daigle said that Pamlab would welcome FDA regulation. Pamlab is probably the largest manufacturer and distributor of medical foods aside from those distributed with hospitals; the privately held company has around 300 employees.

“(It’s) because we follow all the rules and do everything the right way,” Daigle said.

Pamlab has invested millions of dollars in Red River Pharma, a state-of-the-art manufacturing facility in Shreveport. Red River Pharma employs more than 40 people and occupies 60,000 square feet of the Biomedical Research Foundation of Northwest Louisiana’s InterTech Science Park. In the past decade the facility has launched more than a dozen prescription medical food products.

In its lawsuits, Pamlab claimed that the imposter generic makers practiced false advertising, violating a federal law. Pamlab also claimed the imposter firms violated an unfair competition law since their products were not the therapeutic equivalent of Pamlab’s products.

The problem is that a lot of companies enter the medical foods market to make a quick buck, Daigle said, and because there is very little regulation, those firms can get by with making imposter generics.

The manufacturers of imposter goods don’t have to prove their products contain the same ingredients as Pamlab’s, he said. And the current system doesn’t provide for a way to verify the label claims of so-called generic substitutes for prescription medical foods.

According to the lawsuits, Acella and Seton claimed their products contained L-methylfolate, the active ingredient found in Pamlab’s Deplin, used for patients battling addictions and depression, and Metanx, which helps diabetic patients with peripheral neuropathy.

“The companies were not as precise about what they produced and can make huge profits and escape any scrutiny whatsoever,” Daigle said.

According to Pamlab, Deplin helps regulate three monoamine neurotransmitters associated with mood by providing the increased dietary requirements for folate. L-methylfolate is needed by depressed patients with lower levels of folate to regulate the synthesis of serotonin, norepinephrine and dopamine. L-methylfolate, when taken with antidepressants, improves benefits.

Since the medical foods are not covered by insurance, many patients opted for the much cheaper fake generics, and their health suffered as a result.

Small wonder then that some physicians complained that patients who took the alleged generic equivalents of Pamlab products got worse instead of improving.

The Louisiana Attorney General’s Office intervened on Pamlab’s behalf, claiming that patient safety was an issue.

Jim Currie, Pamlab director of corporate communications, said Pamlab has suggested that the FDA require medical foods undergo a testing and approval process akin to that for prescription drugs so that similar conflicts don’t happen again.

Pamlab has completed a number of studies of its medical foods and others are in the works. This year alone, the company has released new clinical data on Metanx and Deplin, among other products.

Last year Pamlab released a study during the New Cardiovascular Horizons Conference in New Orleans. The study found that Metanx reduces numbness in diabetics’ hands and feet.

Dr. Mackie Walker, a St. Louis physician, reviewed an observational study of 31 diabetic patients who had lost feeling in their feet. The patients were treated with Metanx for one year.

Walker found that Metanx eased feelings of numbness by 38 percent at six months and 80 percent by one year.

Pamlab’s products also include Neevo and NeevoDHA, prescribed for women with high- to intermediate-risk pregnancies and who are unable to absorb folic acid; CerefolinNAC, which helps manage metabolic processes identified with early memory loss; and Lunglaid, which helps asthma patients.

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