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Gottlieb confident US FDA being left in good shape, but regrets unfinished work

Departing U.S. Food and Drug Administration Commissioner Scott Gottlieb said he was confident he is leaving the agency in good shape, though he acknowledged some work he had hoped to tackle in his less than two years on the job will be left unfinished.

At a March 19 forum in Washington hosted by the nonpartisan think tank the Brookings Institution, Gottlieb revealed his last working day at the FDA will likely be April 5, a month after he resigned. One of his last duties will be getting grilled on April 3 by House and Senate lawmakers on Capitol Hill about the administration's proposed fiscal 2020 budget.

The remainder of the budget process will be carried out by his temporary replacement, Ned Sharpless, currently the director of the U.S. National Cancer Institute. It is unclear how soon a new candidate will be named by the White House to fill Gottlieb's shoes, if anyone. President Donald Trump has been operating the U.S. government with a number of acting leaders at federal agencies, including cabinet-level positions.

Few immediate shutdown impacts

While the Trump administration is seeking a 12% cut for most of the Department of Health and Human Services agencies, it has called for a 12% boost for the FDA for fiscal 2020.

Gottlieb credited the potential for the added funding as the incentive for some FDA employees staying on at the agency after enduring a grueling 35-day government shutdown, in which over 7,000 of the agency's staff were furloughed from Dec. 22, 2018, to Jan. 25, 2019, while some others worked without pay.

"We haven't seen immediate impacts on hiring," he said, despite the shutdown being the "biggest operational challenge" the FDA has faced in modern times. "We haven't seen an immediate increase in departures."

The long-term impact of the shutdown on hiring and retention of FDA employees will be judged on the perception of government service overall, Gottlieb said, though he said some people may decide to retire who may have otherwise stayed for a few more years.

He said it may take at least six months before the real outcome of the shutdown on hiring and retention is known.

Meanwhile, the FDA expects to hit most, if not all, of the performance goals this fiscal year it has agreed to meet in exchange for the user fees it collects from the industries it regulates, Gottlieb said, repeating what he told the House Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies at a Feb. 27 hearing.

Inspections under scrutiny

Gottlieb, however, said to expect "some slippage" in the overall number of inspections the agency is able to complete this year.

The FDA's inspections of drug manufacturing facilities have already been under scrutiny by Congress after cancer-causing impurities were found in multiple generic forms of angiotensin II receptor blockers, or ARBs, like valsartan. The drugs are used to treat high blood pressure and other cardiovascular conditions, like heart failure.

The FDA has issued a number of recalls of ARBs in recent months.

In February, Gottlieb disputed a series of articles from Bloomberg News that reported "higher-ups" at the FDA had ignored the concerns of agency drug inspectors on the ground about problems at facilities and contaminants in some generic medicines.

In his Feb. 22 statement, the commissioner did not offer any evidence to back up his arguments and the FDA has repeatedly declined to provide S&P Global Market Intelligence any documents or other information on which Gottlieb based his claims.

At the March 19 forum, the commissioner defended his agency's actions on the valsartan and other ARB recalls.

He noted that a change in the manufacturing process by a number of companies resulted in the impurities making their way into the drugs.

"If you didn't know to look for this, this would've been very hard to detect," Gottlieb said. "Nobody knew that this specific process change could produce this specific byproduct until it actually happened."

He said the FDA will be working on strengthening the reporting requirements for manufacturers of active pharmaceutical ingredients so that the agency is fully aware in advance before those companies make changes to their production processes. That way, the agency's team of organic chemists know when to look for potential contaminants, Gottlieb said.

The FDA chief acknowledged the problem should have never happened, but he also tried to assure the public the risk of a patient who took the contaminated products getting cancer was low.

Unfinished business

Gottlieb lamented not being able to see some of the programs he has been working on come to fruition, like reforms aimed at making some prescription products available to patients over the counter, which he said would provide more options at reduced costs.

The commissioner said he also would have liked to have been around to see the legislation intended to establish a modern FDA framework for overseeing in vitro clinical tests, such as test kits and laboratory developed tests, be completed and put in place.

Gottlieb noted he and his agency have been working with lawmakers on the legislation.

In addition, Gottlieb is leaving in the midst of the agency putting various actions in place to help spur the development of biosimilars — drugs intended to be lower-cost versions of biologics, which are derived from natural sources such as microorganisms or plant or animal cells.

While the U.S. has been behind other developed nations in approving biosimilars — there are 18 approved by the FDA, but only a handful on the market — Gottlieb said he remained optimistic.

The greatest impediment to biosimilars is the reluctance of health plans to put the products on their formulary lists of covered medicines because they fear losing lucrative rebates from brand-name manufacturers, the commissioner said.

CBD, e-cigarette issues

Gottlieb also is departing just as the FDA is starting the process of determining how it will regulate hemp-driven cannabidiol, or CBD.

He acknowledged the process for developing CBD regulations is likely to take longer than other rule-making, adding "I don't think that will be done before the next guy leaves."

The FDA is expected to name a working group in the next few weeks to wrangle with the issue, Gottlieb said. The agency is also planning to hold a public meeting on CBD in April.

Gottlieb's exit also comes as the FDA is trying to figure out what to do with regulating e-cigarettes, particularly in light of the increase in the use of those products by America's youth. Rep. Nita Lowey, D-N.Y., chairwoman of the House Appropriations Committee, in February blamed the increase on the commissioner's decision to exempt makers of the vaping devices from premarket reviews until 2022.

Gottlieb, however, insisted there was "no direct line" between the "explosion" in youth vaping and his decision to defer the premarket reviews.