U.S. Department of Justice files suit against AlliancerX in FDA investigation

The Justice Department filed a lawsuit Tuesday against Alliantec Pharmaceuticals, alleging it failed to adequately warn patients about the potential risks associated with using Alliance’s patented anti-aging products, and that it did not adequately protect consumers from the risks posed by its products.

The complaint, filed in U.A.E. Superior Court in Los Angeles, comes as Alliances is being investigated by the U.N. Food and Agriculture Organization (FAO) for allegedly marketing the anti-ageing drugs to consumers who were at least one year out of their 20s.

The Fayetteville, Ark.-based company has been the target of two separate FDA investigations in recent years, including one for failing to warn patients against the risks of its anti-ageding products.

It is also being investigated in Europe by the European Commission, which is investigating whether Allianced failed to report the risks it faced in its markets.

The FDA is also examining Alliancers safety data.

In its complaint, the Justice Department said Alliancys data showed that patients who were one year or older, had not yet attained their age-appropriate age and who had received any prescription drug product containing Alliancing products had a 50 percent higher risk of developing early-onset Alzheimer’s disease compared with those who had not received the products.

Alliances did not provide the FDA with any information about the risk of these patients developing Alzheimer’s, and did not report the fact that their risk had increased, the DOJ said.

“While Allianccys marketing claims that it uses the latest in biotechnology to develop a revolutionary and life-saving product are sound and are supported by the science, the company failed to provide the consumer with any data to support its claims,” the DOJ wrote.

The DOJ said that the company had not provided sufficient evidence to justify its claims.

Alliantec also failed to properly monitor patients for signs of side effects or the development of adverse reactions to its antiageing products, the complaint said.

It failed to educate its customers about the possible risks of using Alliantech products, it alleged.

The company also failed “to provide adequate information to patients about their right to refuse to use its products,” it said.

The Justice Department also alleged that the FDA was not adequately protecting consumers from adverse reactions or adverse effects caused by the Alliancies products, including the development and use of side-effects or adverse reactions.

The U.K.-based health care company, which operates a network of pharmacies and clinics across the U to treat more than 150 million people, has been in the news in recent months after a former employee accused it of using its antiaging products to treat chronic diseases, including Alzheimer’s and Parkinson’s.

Allances’ chief executive officer, John A. MacDougall, said in a statement Tuesday that he was “deeply saddened” by the allegations, and called on the FDA to “work with us to protect our patients.”

He added, “We have made it clear that we are committed to taking this matter seriously and that we will work to cooperate with the government.”

“We are committed, with our partners, to taking the appropriate steps to ensure that we and the FDA are able to fully understand the scope of this matter and the concerns it raises for us and our customers,” he said.

A former Allianck employee who has spoken out against the company, Jeffrey K. Cramer, wrote in an email to Reuters that Allianci “takes great care to avoid taking steps that could result in harm to people.

We believe that the evidence supports the conclusion that the products are safe for use and that Alliantece is taking appropriate measures to ensure the safety of its products.”

The company has denied any wrongdoing.


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