After spending 35 days caught in a partial government shutdown, the U.S. Food and Drug Administration has re-opened for business, though its leader acknowledged that the agency faces what could be many challenges ahead.
It is currently unclear the toll of having thousands of the FDA's employees furloughed for five weeks took on the agency's regulatory work, including the reviews of medical product applications.
In a weekend memo to his employees, FDA Commissioner Scott Gottlieb acknowledged that he had "been candid that it wasn't business as usual" at the agency — a remark he had stated in at least three tweets during the shutdown.
"There will be impacts from this prolonged lapse in funding," Gottlieb wrote in his memo. "But this agency has always faced challenge."
One company, Aimmune Therapeutics Inc., is waiting for the FDA to clarify tweets Gottlieb posted Jan. 14 and 15 that implied the $2.5 million the company paid in user fees before the shutdown started may have been submitted in error.
On Jan. 14, Aimmune revealed the FDA had notified the drugmaker that the regulatory work on the company's peanut allergy medicine application, submitted Dec. 21, 2018 — the day before the shutdown started — would need to wait until the agency was back to normal.
The FDA reopened after the House and Senate adopted a three-week stop-gap measure on Jan. 25 to end the shutdown — a closure that cost the U.S. economy at least $6 billion, according to S&P Global Ratings.
President Donald Trump, however, said he was prepared to close the government again in three weeks or he may "use the powers afforded to me under the laws and the Constitution of the United States to address this emergency" if he does not get the funds he is seeking to build his wall on the U.S.-Mexico border — the issue that triggered the 35-day shutdown.
Trump repeated that threat in a Jan. 27 interview with The Wall Street Journal, saying he doubted any deal congressional negotiators may strike would be acceptable to him. He gave the 17 lawmakers working on an agreement a less than 50% chance of succeeding by Feb. 15.
He also said he likely would hold firm to his $5.7 billion demand for the wall.
Mick Mulvaney, the White House acting chief of staff, said on NBC's Meet the Press on Jan. 27 that the administration had identified more than that amount it could take from various federal agencies if Trump decides to use the national emergency declaration — an option Sen. Marco Rubio, R-Fla., called a "terrible idea."
For the time being, however, Gottlieb is concentrated on getting his operations back up to speed after 54% of his staff were either fully or partially furloughed.
"Now we're set to return to a fully operational agency and you have my commitment that I will support you as you return our programs to their full strength and continue to advance your important public health goals," the commissioner wrote in his weekend memo.
At a Jan. 18 public hearing, Gottlieb had called the shutdown "one of the most significant operational challenges in FDA's recent history," adding that the agency was "in unfamiliar territory."
The FDA, which has struggled to fill a number of open positions in recent times, could be losing nearly half of its senior leadership to retirement over the next two years.
In a series of tweets on Jan. 27, Gottlieb said he planned to "personally greet many" of the furloughed FDA employees on their return back to work the next day, calling their absence "palpable."
The commissioner also tweeted details about where employees could seek assistance about their benefits, pay, information technology issues, badging and other shutdown-related matters at the agency's headquarter White Oak campus outside in Maryland — a signal he may be anticipating a chaotic week ahead.
On the agency's first full day of operations on Jan. 28, Gottlieb also was scheduled to give the keynote address ahead of a panel discussion by three former FDA commissioners at a public forum in Washington hosted by the Bipartisan Policy Center.
House hearing to focus on FDA shutdown
Meanwhile, the effects of the shutdown on the FDA's workers and the industries the agency regulates are expected to be a key focus at a Jan. 31 House Energy and Commerce Committee hearing examining the partial government closure, a spokesman for the Rep. Frank Pallone, D-N.J., the panel's chairman, told S&P Global Market Intelligence.
"When this shutdown began, I never imagined that it would have lasted this long," Pallone said in a statement late last week.
In light of the newly scheduled hearing, the New Jersey Democrat has temporarily postponed three other sessions he had planned to hold to investigate the Trump administration's refusal to defend the Affordable Care Act in an ongoing lawsuit — now being appealed — its policy to separate immigrant children from their families at the border and climate change.
Lobbyists urge lawmakers to run from foe Doggett
The House and the Senate also will hold hearings on drug pricing matters this week — one convened in the upper chamber by Sen. Chuck Grassley, R-Iowa, head of the Finance Committee, and the other in the lower chamber by Rep. Elijah Cummings, D-Md., chairman of the Oversight and Reform Committee.
The hearings, both on Jan. 29, are expected to focus on legislation authored by the respective chairmen aimed at lowering Americans' drug costs.
Rep. Lloyd Doggett, D-Texas, chairman of the House Ways and Means Health Subcommittee, plans to soon reintroduce his legislation to let the government's Medicare program for seniors and disabled Americans negotiate drug prices directly with biopharmaceutical companies, according to his aide, Afton Cissell.
Under Doggett's bill, if a brand-name company refused to negotiate with Medicare, Health and Human Services could grant a competitive license to generic drugmakers allowing them to produce cheaper copies of the innovator's medicine, Cissell said during a Jan. 24 forum hosted by the patient advocacy group Families USA.
The innovator company, however, would receive a reasonable patent fee, Cissell added.
When Doggett initially introduced the bill in July 2018, over 100 Democrats signed on as co-sponsors, the aide noted.
Shawn Gremminger, senior director of federal relations at Families USA, said Doggett's bill had the best chance to succeed of any of the drug pricing measures currently on Capitol Hill.
"If we had to choose one, it's the strongest one out there," Gremminger said.
But drug industry lobbyists — the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization — have been pushing back hard against Doggett's legislative efforts, Cissell said.
PhRMA and BIO already have swarmed new House Democrats, urging them to "run away" from Doggett if he tried to approach them to back his legislation, Cissell said. The aide said she has gotten a number of calls from those freshmen lawmakers' offices about such lobbyists' tactics.
"Those are the kinds of forces we are dealing with and they are successful at times," she said. "There are members that get really scared about this. It is a real uphill battle to get to some of the transformational challenges that we are talking about."
PhRMA reported it had spent $27.52 million on lobbying activities in 2018 — an all-time high for the group — while BIO spent 9.87 million, according to the U.S. Lobbying Disclosure Act Database.
State efforts to rein in drug prices
At the Families USA Health Action conference last week, Maryland Attorney General Brian Frosh also emphasized that many states were pursuing their own efforts through legislation and litigation to bring down drug prices.
Frosh said he is waiting to hear whether the U.S. Supreme Court will take up Maryland's petition to reverse an April 2018 ruling by the U.S. Court of Appeals for the Fourth Circuit that said the state's 2017 law that targeted generic drug price-gougers was unconstitutional.
The Association for Accessible Medicines, which represents generic manufacturers, filed the lawsuit, arguing Maryland's law gave the state unprecedented powers to regulate the drug industry.
Maryland also is among 20 states suing 18 generic drugmakers for price fixing, Frosh noted.
"They got together and carved up the markets," Frosh said. "And they just jack up the prices of your products."
He said the evidence, which includes emails, revealed a "clear plan to fix prices and to cheat consumers."