WASHINGTON -- Drug companies that block generic competitors by preventing the latter from accessing samples to study should consider themselves "on notice," said FDA Commissioner Scott Gottlieb, MD, at a briefing Tuesday.
Last week, President Trump announced a multipronged approach to curbing high drug prices, which Health and Human Services Secretary Alex Azar, JD, further clarified during a briefing with reporters on Monday.
Gottlieb explained the FDA's role in increasing product competition at the Tuesday briefing, hosted by the Alliance for Health Policy and APCO Worldwide, a global public affairs consultancy.
The FDA will launch a website Thursday identifying 50 brand-name drugs whose makers, according to generic drug companies, have blocked them from accessing samples of their drugs, which are needed to prove bioequivalence and ultimately gain generics' approval, Gottlieb said.
"I'm not looking to shame drug companies ... I'm looking to bring transparency around what I think are reasonable public health questions," he stated.
This type of information will allow "you all" (reporters) to decide the "root cause" of any access issues, he added. For example, an access problem may relate to a Risk Evaluation and Mitigation Strategy (REMS) or a distribution contract.
Generic drug companies have long complained that brand-name manufacturers hide behind REMS protocols, using them as an excuse for not making drug samples available because of safety concerns. Delaying access to samples allows the brand manufacturer to extend its own exclusivity period. Another tactic brand-name drug companies sometimes employ is to enter into restrictive contracts with distributors.
About 50 drug companies will be identified as subjects of inquiries by generic drug companies on the new website.
The agency received 150 letters, and some drugs were targeted in as many as 10 different letters, Gottlieb noted. The FDA will not reveal the names of the generic companies that wrote the letters, only the names of the drugs, he said.
In each case, the FDA will state whether a REMS was in place, and whether the REMS included an Elements To Assure Safe Use (ETASU) provision.
If no REMS is in place, and there are multiple inquiry letters, then there may be a distribution restriction, such as a specialty pharmacy being contractually prevented from providing samples to generic drug companies. Gottlieb stressed that "would be speculation on my part."
Gottlieb said the website will also indicate if the agency sent a "safety determination letter" -- a letter assuring the brand-name company that the generic will satisfy all of the requirements of the brand company's safety protocol.
He noted that the FDA has not made any judgment regarding the validity of inquiry letters from the generic manufacturers, which have not been reviewed by the Federal Trade Commission.
In addition, the FDA plans to issue waivers that would allow generic drug makers to have their own REMS instead of one shared with the brand-name manufacturer. This would address situations where a brand-name company has relied on REMS to block generics access to sufficient doses of their products. Guidance on these waivers will be issued at the end of May, he added.
The guidance should put brand-name manufacturers on notice that generics will soon be allowed to "go their own way," Gottlieb suggested.
Waivers will serve as a "visible reminder that something was going on," he said. Ultimately, "the branded company ... too would prefer a single-shared REMS; they just would prefer [it to happen]...maybe 12 months later."
Asked about the (Creating and Restoring Equal Access To Equivalent Samples Act of 2017) that aims to improve generic competition by ensuring adequate access to sample drugs, Gottlieb said the administration had provided technical assistance with the bill, but had not taken any formal position as far as an endorsement.
Gottlieb also said "fundamental restructuring" of the FDA drug approval process would "elevate the function of medical reviewers" and allow greater collaboration among consultants with different expertise. The agency could then produce a single integrated review memo for each drug that would be fully searchable and housed in the cloud, rather than countless, individual PDFs. The ultimate goal would be a more collaborative, more transparent review process, he said.
Gottlieb also highlighted more direct strategies for increasing price competition.
When Medicare Part D, the prescription drug benefit, was created in 2006, most Medicare Part B drugs were single-source drugs without any competition, he said.
Today, however, there is greater competition among Part B drugs. Generally speaking, in cases where there is therapeutic equivalence, plans negotiate prices using drug formularies, step therapies, or preferred tiers, he said.
On Monday, Azar said HHS officials are considering moving some or all Part B drugs into the Medicare Part D program as a way of negotiating more competitive prices.
While there have been some concerns that this shift could cause Part D premiums to rise, Gottlieb said he believes the savings that result from the change "would be more than enough ... to subsidize the premiums in Part D in a way that the patient ... won't be adversely impacted."
Finally, Gottlieb said an agency working group was evaluating whether the FDA could require drug companies to disclose their prices, including in direct-to-consumer advertising,
Whether such a requirement could be considered "compelled speech" is a legal question the agency is still studying, he said.
"I don't want to get too far ahead of the process," he cautioned, which could take multiple months.
Asked whether including list prices in ads might deter patients from even telling their doctors about a particular condition, Gottlieb suggested that a different type of price -- whatever the agency determines is the best proxy for what most patients actually pay -- could also be used.
He suggested the drug industry could do this voluntarily as part of a "code of conduct."