These 4 Big Smears Against FDA Pick Scott Gottlieb Are All Wrong

These 4 Big Smears Against FDA Pick Scott Gottlieb Are All Wrong

On Wednesday, a Senate committee will hold a hearing on President Trump’s appointment of Dr. Scott Gottlieb as commissioner of the Food and Drug Administration.
Margot Cleveland
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On Wednesday, a Senate committee will hold a hearing on President Trump’s appointment of Dr. Scott Gottlieb as commissioner of the Food and Drug Administration. While Gottlieb is extremely qualified to lead the FDA as a physician, professor, scholar, and former FDA deputy director, the Left has already launched some top-shelf histrionics.

Here are the top four charges wrongly leveled at Gottlieb, which you can expect to resurface during the Senate Committee on Health, Education, Labor, and Pensions’ (HELP) hearing.

1. In The Pocket of Big Pharma

Following the announcement of Gottlieb’s selection, the Left began painting Gottlieb as, at best, an unscrupulous stooge in the pocket of the pharmaceutical industry, and, at worst, the personification of Big Pharma. For instance, the liberal public interest group Public Citizen quickly issued this attack statement:

Gottlieb is entangled in an unprecedented web of Big Pharma ties. He has spent most of his career dedicated to promoting the financial interests of the pharmaceutical industry and the U.S. Senate must reject him.

Gottlieb’s ties span decades, and he currently is serving or has recently served on five pharmaceutical companies’ boards including GlaxoSmithKline – one of the world’s largest pharma companies. Between 2013 and 2015, Gottlieb received a total of at least $413,000 from multiple pharma and medical device companies, most for consulting and speaking fees.

It is entirely appropriate for the HELP Committee to assure that Gottlieb can disentangle himself from conflicts of interest. But in the run-up to the hearing, liberals unfairly and inaccurately demonized drug companies and cast Gottlieb as complicit with pharma through guilt-by-association.

While this narrative plays well with the Left’s base, it is entirely misplaced. Not only is it wrong for politicians to castigate the pharmaceutical industry, it is also hypocritical for senators to condemn Gottlieb for his consulting work. Gottlieb is an expert on pharmaceutical issues, which is why drug makers and senators have sought his guidance. Gottlieb has testified as an expert witness 18 times before Congress, most recently speaking at the HELP Committee’s field hearing on Epi-Pen price increases.

Nonetheless, given the Left’s obsession with Big Pharma, they’ve launched over-the-top attacks.

2. Culpable for High Drug Prices

A closely related but more focused charge has leveraged the media’s incessant coverage of drug price “scandals” in the past year. What started with the press’s obsession over Turning Pharmaceutical’s Martin Shkreli soon added Mylan and the EpiPen scandal to its repertoire. Most recently, Marathon’s $89,000 price tag for a Duchenne muscular dystrophy drug caught the attention of journalists and politicians alike.

Since his appointment, the Left has rerun these headlines, tying Gottlieb to these pricing “scandals” by stressing the pharmaceutical industry consulting fees he has received, including $156,000 from Vertex, a pharmaceutical company with two high-priced drugs on the market: Kalydeco (priced above $300,000 per year) and Orkambi (priced in the mid-$200,000s).

But these attacks are pure grandstanding because, while liberals like to bemoan the high price of drugs, the FDA Gottlieb may lead lacks the authority to establish drug prices or even consider drug costs in its approval process. Gottlieb has also proposed specific, market-based reforms that will reduce prices by increasing competition and lowering regulatory costs.

Liberals, however, prefer price-fixing for drugs despite the damage this does to sick patients, so their posturing continues.

3. Putting Patients At Risk

While the press and leftist “public interest” groups have openly attacked Gottlieb, politicians on the left side of the aisle have been more circumspect (read passive-aggressive). For instance, following Gottlieb’s appointment, Democrats’ ranking HELP Committee member, Patti Murray, tweeted a seemingly benign comment that the FDA must put patients and families first, linking an article focusing on Gottlieb’s “deep drug-industry ties.”

Murray later leaned in from her tweet in a statement addressing Gottlieb’s nomination: “In beginning to evaluate Dr. Gottlieb’s nomination, I have initial concerns about how his views would impact our ability to maintain the gold standard of FDA approval.”

Two main problems with the gentle lady’s concerns: First, in passing the Twenty-First Century Cures Act last year—with Murray’s support—Congress has already authorized the FDA to deviate from the so-called “gold standard” of clinical trials and to consider real-world evidence in the drug approval process. Given this mandate, Gottlieb cannot limit the FDA to evidence meeting the so-called “gold standard.” Second, an unbendable rule requiring pharmaceutical companies to establish drug efficacy solely through placebo-controlled trials both harms patients and increases pharmaceutical costs.

Nonetheless, given that two senators on the HELP Committee—Bernie Sanders and Elizabeth Warren—voted against Twenty-First Century Cures Act, it is likely that the committee will revisit their prior criticism of the “real-world” evidence provisions of that statute.

Critics have also condemned Gottlieb for statements about off-label marketing by pharmaceutical companies, claiming that loosening the current standards would harm consumers. Such criticisms, however, ignore the valid pro-patient reasons to allow drug companies more flexibility in sharing information with doctors about off-label uses, which is why the FDA has already been exploring this issue. In November 2016, the FDA held a public meeting on off-label communications and recently sought additional public comment about permitting this, explaining:

Health care professionals already can access considerable scientific information about unapproved uses, for example, through public sources such as scientific journals, clinical practice guidelines, and compendia or by requesting that information from firms. …FDA is interested in comment and information addressing whether and in what ways firms’ communications of unapproved use information are distinct and perhaps provide unique benefits compared to other sources.

In short, while liberals may disagree with Gottlieb’s position, charges that he lacks concern for patients are flatly wrong. Those who have worked with Gottlieb, such as John Taylor, a former FDA lawyer, have said as much, telling The New York Times that “Scott and I have different ideological backgrounds, but I recognize that he does have a record of doing things that are for the benefit of the consumers.”

4. Gottlieb Threatens Birth Control

Murray also showcased a second passive-aggressive charge in her statement on Gottlieb’s selection, writing: “I have also long fought to ensure that medical expertise—not ideology—governs FDA decision-making on critical products, including Plan B, and would find it unacceptable if a nominee for FDA Commissioner showed any sign of failing to uphold that basic standard.”

It is unclear why Murray singled out Plan B in this statement. It is likely just a ruse to chest-pound about “reproductive rights” thanks to the Plan B controversy President Obama’s tenure raised. But while the Plan B pitch is unlikely to fly, it would be fascinating if the Right pivots off Murray’s statement during the hearing to discuss making the birth control pill available over-the-counter. If that happens, expect the liberals on the committee to backtrack quickly, given their opposition to Sen. Cory Gardner’s 2015 proposal to move the pill from behind the pharmacists’ counter.

It would be fascinating if the Right pivots off Murray’s statement during the hearing to discuss making the birth control pill available over-the-counter.

Ironically, at the time of Gardner’s proposal, Murray responded, “We have to be very careful not to put political pressure on the FDA….” But a lot can change in two years, especially when there’s a presidential election in the interim.

Given Gottlieb’s unparalleled qualifications, the hearing should leave him unscathed and his Senate confirmation should follow soon after. That’s when Gottlieb will face his first real challenge: Implementing his free-market vision for the FDA within the Trump administration’s populist push for capping drug prices.

Given Health and Human Services Secretary Tom Price’s recent testimony before a House subcommittee “that his agency is working with President Donald Trump on a plan to bring down the cost of pharmaceutical drugs,” Gottlieb is likely to find his first toss-up isn’t with liberal critics who oppose regulatory reform, but with his boss.

Gottlieb has already tangoed with Trump on drug prices, but that was before their respective roles changed. If Gottlieb can successfully lead the administration away from a harmful price-fixing model and towards a free-market fix, he will have proven his mettle right out of the gate. But that is a bigly if.

Margot Cleveland is a senior contributor to The Federalist. Cleveland served nearly 25 years as a permanent law clerk to a federal appellate judge and is a former full-time faculty member and current adjunct instructor at the college of business at the University of Notre Dame.
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