BIO 2018: Gottlieb defends naming drug makers, outlines office efforts

Sometimes the pharmaceutical industry is putting in place barriers to generic makers’ ability to get access to and samples of drugs, according to Scott Gottlieb, commissioner of the US Food and Drug Administration (FDA).

Gottlieb was speaking to attendees at the 2018 BIO International Convention, which took place in Boston between Monday, June 4 and yesterday, June 7.

Last month, the FDA made public a list of companies that have potentially been blocking access to the samples of their branded products.

A generic drug developer generally needs between 1,500 to 5,000 units of the brand drug to perform studies for FDA approval.

“They’re saying that we’ll buy it but we can’t buy it, and that’s frustrating,” added Gottlieb about the generic companies.

Gottlieb said he does not want this system being manipulated, by branded pharmaceutical companies or even generics.

“If we believe that it’s being abused [by the generics], we could put in place a stipulation that if the generic company doesn’t approach us, we’ll make the generic company’s name public too. I think that would put in place a speed bump to make sure they are serious,” he added.

Gottlieb then moved on to the biggest challenge facing the FDA—the opioid crisis.

“One of the things that worries me is that, lately, the abuse crisis is shifting from a crisis that began with the abuse of drugs lawfully prescribed [for pain management] to one that is increasingly a crisis of street drugs,” said Gottlieb.

He added that this changes the “complexion” of how the FDA addresses the crisis and the demographic of the people becoming addicted.

Earlier this week, the FDA announced it had warned nine online networks, which operated a total of 53 websites, that they must stop illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications.

“I don’t want to find out five years from now that we were at the cusp of an emerging shift in the crisis that we didn’t get ahead of. We don’t want to be one step behind any more,” he concluded.

Turning to gene therapy, Gottlieb said that there were “hundreds” of gene therapy investigational new drug applications in place at the agency.

In July this year, the FDA will release six documents aimed at creating a modern framework for the agency’s approach to gene therapy.

Last year was a record year for the agency—in August, the FDA made the first gene therapy available in the US. This was Novartis’s Kymriah (tisagenlecleucel) for certain paediatric and young adult patients with a form of acute lymphoblastic leukaemia.

It was soon followed by approval for a CAR T therapy, a treatment by Gilead-owned Kite, and the approval of a gene therapy to treat patients with a rare form of inherited vision loss.

Gottlieb believes this is a sustainable effort, given that a lot has “been in motion for many years”.

“It would be disingenuous for me to say we implemented new policies in the first month in office. It’s been in the process a long time,” he said.

While there was a slow down in generic approvals earlier in the year, driven by changes imposed on certain agency features, Gottlieb is confident the office will catch up, if not surpass, the rate of approvals last year.

The 2018 BIO International Convention finished yesterday, June 7.

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