With FDA chief gone, doubts rise on battles on nicotine, opioids, drug costs

fdachiefgottlieb-150x150The Trump Administration has lost yet another top health official: So, what happens now with key policies pushed by Scott Gottlieb, the departing federal Food and Drug Administration commissioner, to battle teen nicotine abuse, cut skyrocketing drug costs, and attack the opioid crisis?

Administration officials insist Gottlieb wasn’t ousted, and the physician and onetime Big Pharma insider said he resigned from his post after a year on the job because he wanted to spend more time with his family (they hadn’t moved from Connecticut to join him in the nation’s capital).

Though Gottlieb received mixed or favorable media coverage as he leaves, his effect on the nation’s health is as cloudy as many high school vaping spots.

After postponing a crackdown on vaping and e-cigarettes — purportedly to study them more and consider how to deal with addictive and damaging nicotine — Gottlieb found himself grappling with the Juul phenomenon: an e-cigarette maker, armed with a small and alluring device, turned vaping and nicotine consumption into a hot and huge youth fad. Research has found that as many as 1 in 5 young Americans have experimented with vaping, which also is becoming a gateway to burned tobacco products, notably cigarettes with their proven cancer and other disease-causing harms.

Gottlieb hit the alarm buttons and sought to crack down on vaping, e-cigarettes and the flavored liquids catalyzed in them, as well as on underage tobacco sales and flavored cigarettes.

But as he toughened the FDA tactics the commissioner also ran up against Big Tobacco—a major brand from which had bought a $13 billion, 35 percent stake in Juul, as well as in a legal marijuana enterprise—and formidable retail interests like Walmart and Walgreens. Further, though their grumbling was muted, lawmakers from tobacco states and conservatives in Congress bristled at Gottlieb’s government activism against big business.

It’s unclear if the Administration, as it has in other federal agencies, will elevate an existing FDA executive or install someone new as an interim or full appointee. With the clock already ticking on the 2020 presidential campaign, the president has been disinclined to follow norms of his office and nominate top administration officials and see them then undergo hearings that allow lawmakers to advise and consent on his picks.

That makes even murkier the prospects for not only a sustained campaign against vaping, e-cigarettes, flavorings, and flavored tobacco products, it also puts in doubt at least two other key pushes by Gottlieb to cut drug prices and bolster the battle against opioids.

The commissioner had focused on the potential for generic drugs to reduce skyrocketing prescription drug prices. Generics, products on which the original makers’ patents have lapsed, typically cost far less, especially because the research and development costs for them have been written off and they don’t get the whopping advertising and marketing budgets devoted to brand names.

The FDA, under Gottlieb, pushed to review and approve generics, boasting that record numbers of these drugs would benefit ordinary Americans’ pocketbooks. There was a catch to this, though: Kaiser Health News Service analyzed the more than 1,600 generics approved since January 2017 and found that “43 percent [or so of them] …weren’t on the market as of early January,” and “36 percent of generics that would be the first to compete against a branded drug are not yet for sale.”

As the nonprofit, nonpartisan health and medicine news service also reported:

The approved generics that haven’t made it to American medicine cabinets include generic versions of expensive medicines like the blood thinner Brilinta and HIV medication Truvada. They also include six different generic versions of Nitropress, a heart failure drug, whose price spiked 310 percent in 2015. [They aren’t getting to market because generics] sellers have fought for years against patent litigation and other delay tactics that protect brand-name drugs from competition. In recent years, vast industry consolidation has reduced the ranks of companies willing to purchase and distribute generics. And, in some cases, makers of generics obtain approvals and ultimately make a business decision to sit on them.

As for the FDA and opioids, Gottlieb received praise in many quarters for supporting an evidence-based but still controversial approach to treating abusers with the drug naxalone. He brushed back critics who ask if it makes sense to treat drug abuse with another drug.

Though the agency recently announced yet more steps to attack opioid abuse, including labeling and dosage changes, the FDA also drew fire for calling for yet more study of the powerful and addictive painkillers, including if they lose effectiveness quickly as users bodies adapt to them.

Gottlieb also took fire for the agency’s approving Dsuvia, an opioid painkiller of huge potency developed with the U.S. military for potential battlefield use. Critics asked why the nation needed yet another opioid, especially when officials had failed to control others.

In my practice, I see not only the harms that patients suffer while seeking medical services, but also their struggles to access and afford safe, efficient, and excellent medical care. This challenge only grows as the complexities soar and the costs skyrocket for therapies and prescription drugs, including too many like opioids that prove to be dangerous for patients and damaging for their loved ones. The damage that Big Pharma, doctors, hospitals, insurers, and others have inflicted on the nation via the opioid crisis was driven home yet again with news that the country, sadly, set a record for deaths of despair, lives lost to alcohol, drugs, and suicides.

Names already are surfacing as possible Gottlieb replacements. The American people deserve not only a quality nominee but also some commitment to the giant health challenges confronting the nation. Can an interim commissioner or another bad health choice by this administration safeguard our kids against Big Tobacco and fight off the damages of Big Pharma, whether through prices or putting out risky products? Can a weak chief follow through on the announced crackdown on costly and sketchy supplements?

In the first half of this administration, two Trump officials have been ousted — for taking taxpayers for a ride with pricey private flights and for failing to pull her hand out of her personal cookie jar (trading stocks) while trying to regulate companies, including Big Tobacco. Gottlieb, to his credit, tackled his job with professionalism, though not necessarily with best outcomes. It’s hard to see how, though, any federal agency performs optimally if the president and his men can’t do a significantly better job in getting great talent and keeping it in place.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
Washingtonian Top Lawyer 2011
Avvo Rating 10.0 Superb Top Attorney Best Lawyers Firm
Contact Information