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Gottlieb sets a new standard for FDA commissioner

Scott Gottlieb, M.D.

Dr. Scott Gottlieb has taken industry skeptics by surprise.

When the Trump administration tapped Gottlieb to lead the U.S. Food and Drug Administration last year, branded-drug manufacturers and their investors celebrated. Others were less exuberant.

Industry observers expected Gottlieb, who advised GlaxoSmithKline and was a board member for several other drug and device makers, to protect Big Pharma’s interests.

Yet, about a year later, the FDA commissioner has quieted many of his critics. An unprecedented level of transparency and public disclosure has garnered support from across the industry. Gottlieb has tried to curb drug prices by introducing more generics. The public health community praised his policies that look to lower salt content in food and nicotine in cigarettes, as well as crack down on opioid distributors and websites.

“This is the most prominent FDA commissioner in terms of getting out in front of the public,” said Jim Shehan, senior counsel with Lowenstein Sandler and chair of the firm’s FDA regulatory practice, adding that Dr. David Kessler, who ran the agency for much of the 1990s, was likely the second-most. “It’s uncommon to win approval on both sides. The commissioner tends to be more of a target than someone people congratulate.”

The FDA declined to comment for this article.

Gottlieb has been particularly vocal about speeding the approval of generic drugs and ending the “shenanigans” that thwart competition. The FDA published a list of off-patent branded drugs without approved generics and prioritized generic-drug applications for branded drugs that have fewer than three competitors. The agency also cleared the orphan-drug request backlog as it aims to streamline its application process, and has made a significant dent in the backlog of generic-drug applications.

Those efforts, aided by the increase in staff related to the renewal of the Generic Drug User Fee Act, have seemingly paid off. The FDA approved 763 abbreviated new drug applications in 2017, outpacing 2016’s record high by 112 approvals.

Generic drugs now account for nearly 90% of prescriptions and saved the healthcare system $1.46 trillion from 2005 to 2015, according to the QuintilesIMS Institute. Drug prices are cut in half when two manufacturers are producing a generic, according to the FDA.

“He is in the best position to separate fact from fiction in determining what the right policy is moving forward,” said Chip Davis, CEO of the Association for Accessible Medicines, which represents generic-drug makers. “He has expanded the importance of the role of the FDA commissioner to a public role, and done so with a purpose.”

The agency announced new policies related to its Risk Evaluation and Mitigation Strategies program so branded-drug makers couldn’t prevent potential generic competitors from gaining approval to market their product. Branded manufacturers may be using REMS to manipulate the process on the back end when tested generics are trying to enter the market, according to Gottlieb. The agency singled out 52 medicines for which generic-drug makers couldn’t obtain samples.

Like previous commissioners, Gottlieb looks to tackle the public health burden of tobacco use. The FDA said it would limit the amount of nicotine in cigarettes, which Gottlieb described as a “historic first step.”

The commissioner has tried to combat chronic disease by requiring restaurants to post calorie counts. The FDA also aims to modernize nutrition facts and implement voluntary sodium reduction targets.

As for the opioid crisis, the FDA got the drugmaker Endo Pharmaceuticals to withdraw its opiate pain-killer Opana ER, saying the medication’s risks outweigh its benefits.

It’s one of the first times the FDA has tried to get an opioid pain medication off the market because of the public health consequences of abuse.

The agency placed new restrictions on the use of opioids in children’s cold and cough products as it reassesses its evaluations of opioid products before and after they reach the market. This month, the FDA said it warned nine online networks that operate 53 websites that they must stop illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications.

The FDA encouraged drugmakers to develop abuse-deterrent opioid formulas and medication-assisted treatments. Gottlieb also asked health insurers to cover opiate alternatives.

New efforts to encourage the sale of the opiate-overdose reversal drug naloxone over the counter are in the works and the agency approved a more effective form of buprenorphine, which is used in medication-assisted treatment for opioid addiction.

“From combating opioid addiction to enhanced uses of digital health technologies, we’re seeing a more modernized regulatory agency that is not standing still when it comes to helping patients while ensuring the safest standards in the world,” Scott Whitaker, CEO of AdvaMed, which represents the medical device industry, wrote in a statement.

But industry experts said Gottlieb and the FDA still have work to do.

Hurricane Maria put the spotlight on the drug shortage problem as critical saline supplies disappeared, but the industry has struggled with shortages for years. The FDA seeks to clarify information the agency requires to adequately prepare for shortages, prioritize drug approvals for those in short supply and implement new technology that mitigates manufacturing problems, but more could be done, according to the American College of Emergency Physicians. That is why the group sent a letter to the FDA, with the support of more than 100 members of Congress, to convene its Drug Shortage Task Force with other relevant federal departments to get ahead of shortages.

While the agency has covered a lot of ground on speeding the approval process, it has lagged on the regulatory requirements that put costly burdens on generic manufacturers to generate data, said Coleen Klasmeier, head of the food, drug and medical device regulatory practice at law firm Sidley Austin.

“It shouldn’t cost $50,000 to generate data to support market authorization,” she said.

While around 150 generic-drug manufacturers sought the FDA’s help in obtaining branded-drug samples, that issue is only a small slice of the pie, Klasmeier added.

For biosimilars, which replicate expensive biologics, 11 applications have been approved and only three are on the market. “If that ratio continues, companies will stop developing them,” Davis said.

AbbVie filed 100-plus patents within a year of the patent expiration of the main ingredient of its blockbuster rheumatoid arthritis drug Humira to protect its dominant market share. Tactics like this are a detriment to the entire industry, Davis added.

“It would take biosimilar developers years to knock down those patents,” he said. “That fits into the larger dynamic of his focus on anticompetitive behavior, but it requires congressional engagement.”

And there’s been little progress in taking on pharmacy benefit managers and curtailing frivolous litigation, despite stated plans to do so, said Scott Knoer, chief pharmacy officer at the Cleveland Clinic.

Similarly, Gottlieb hasn’t done enough to prevent branded manufacturers from pursuing tactics like evergreening, pay for delay, citizen petitions, manipulating the Orphan Drug Act, and other anticompetitive behaviors, he said.

“He seems to understand the underlying issues and has addressed the low-hanging fruit, but Congress needs to pass legislation to support his vision before real progress can be made,” Knoer said.

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