“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 previously said brand-name drug companies' “shenanigans” to stall competition must stop and sent out a statement that the website would highlight “where drug makers may be pursuing gaming tactics to delay generic competition.”
The 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.
Jeremy Greene, a professor of medicine at Johns Hopkins School of Medicine said that this was an important first step, but pointed out that shame, alone, may not be a powerful enough incentive to change behavior. Martin Shkreli became a celebrity villain when he increased the price of an antiparasitic medication called Daraprim by 5,000 percent -- but the price of that drug hasn't changed.
"If the case of Daraprim and Turing Pharmaceuticals is any guide, public shaming alone is not likely to end these anticompetitive practices," Greene said in an e-mail. "A world’s worth of public shame was not enough to encourage the company to bring the price back down."
“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, 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.”
Novartis spokesman Eric Althoff said the company disagrees with the inclusion of its medicines on the list and, as a maker of generic drugs through its Sandoz unit, supports the development of generic products.
“To our knowledge, there are no restrictions preventing generic manufacturers from accessing these Novartis products and we have communicated that to generics companies that have contacted Novartis with similar requests,” Althoff said.
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 and a pulmonary arterial hypertension drug from Gilead.
“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 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. House Speaker Paul D. Ryan (R-Wis.) spoke Thursday about working on a compromise on the bill at a BakerHostetler legislative seminar.
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 and Gilead did not immediately respond to requests for comment.