FDA shames drug companies suspected of using 'gaming tactics' to delay competition

Thursday , May 17, 2018 - 11:20 AM

Carolyn Y. Johnson

(c) 2018, The Washington Post.

To lower drug prices, the Trump administration is trying public shame.

On Thursday, the Food and Drug Administration posted a list of more than three dozen drug companies that may be restricting access to samples that generic drug companies need in order to make cheaper copies of medicines used to treat conditions and diseases such as acne, cancer and HIV.

The companies with the most complaints include Celgene, Gilead Sciences, Johnson & Johnson’s Actelion and Novartis. Generic drug companies requested FDA assistance in receiving samples of a variety of drugs from those companies.

“We know that certain brand name manufacturers are abusing the system by blocking access to samples, and hiding behind FDA’s rules when they do it,” Health and Human Services secretary Alex Azar said in a Monday speech about the administration’s drug price plan. “FDA is going to begin publicly identifying drug companies suspected of engaging in these abusive practices.”

FDA commissioner Scott Gottlieb has said brand name drug companies’ “shenanigans” to stall competition must stop.

FDA said Thursday that it has received more than 150 requests from generic drug companies for the agency’s help in obtaining samples. In some cases, the brand name drug companies may invoke an FDA program to limit distribution for drugs that carry major risks, such as birth defects. In others, brand name drug companies use contracts with distributors and wholesalers to limit distribution of their drugs.

“This is a great day for patients, since the Administration’s list makes the definitive case why brand-name drug companies must stop blocking generic competition,” said Allen Goldberg, vice president of communications for the Association for Accessible Medicines, the generic drug lobby.

The pharmaceutical lobby, the Pharmaceutical Research and Manufacturers of America (PhRMA), released a statement expressing concern over the move.

“While we must continue to foster a competitive marketplace, PhRMA is concerned that FDA’s release of the ‘inquiries’ it has received lacks proper context and conflates a number of divergent scenarios,” spokesman Andrew Powaleny said in an email. “Additional context is essential.”

The drug with the most complaints was Actelion’s Tracleer, a drug for a rare condition that causes high blood pressure in the lungs, called pulmonary arterial hypertension. That was followed by Celgene’s cancer drugs, Revlimid and Thalomid.

“We’re taking these steps today because we believe greater transparency will help reduce unnecessary hurdles to generic drug development and approval,” Gottlieb said in a statement. Gottlieb added that the agency also will alert the Federal Trade Commission and urged generic companies to provide information directly to the FTC on anticompetitive business practices.

A bipartisan bill, the CREATES Act, would help generic drug companies obtain samples. It was dropped from the Bipartisan Budget Act in February under heavy pressure from the brand name pharmaceutical industry.

Rep. Frank Pallone Jr., D-N.J., released a statement urging the passage of legislation.

“There is no reason to think that a public list shaming pharmaceutical companies for blocking generics from coming to market will compel them to compete fairly,” Pallone said.

In a statement, Celgene emphasized the importance of the FDA safety rules, pointing out that the multiple myeloma drug Thalomid (thalidomide) is associated with severe birth defects.

“These therapies are subjected to rigorous safety controls that have been developed by the company and approved by the FDA,” spokesman Greg Geissman wrote in an email. “Celgene has sold and will sell our groundbreaking products to generic manufacturers for the purposes of bioequivalence testing, subject to reasonable safety-related and business requirements. Generic versions of Thalomid and Revlimid are licensed to enter the market in coming years.”

Actelion, Gilead and Novartis did not immediately respond to requests for comment.

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