Critics fear a key watchdog’s decline as FDA eases up its regulatory actions

fdagottlieb-240x300Consumers may want to think long and hard about whether the federal Food and Drug Administration protects the interests of the vulnerable public or profit-raking Big Pharma and medical device makers.

As a scrutiny of data by Science magazine  shows:

“From monitoring clinical trials and approving medicines and vaccines, to ensuring the safety of blood transfusions, medical devices, groceries, and more, the U.S. Food and Drug Administration (FDA) is one of the nation’s most vital watchdogs. By several measures, however, FDA’s compliance and enforcement actions have plummeted since President Donald Trump took office … The agency’s ‘warning letters’—a key tool for keeping dangerous or ineffective drugs and devices and tainted foods off the market—have fallen by one-third, for example. Such letters typically demand swift corrections to protect public health and safety. FDA records from Trump’s inauguration through 22 May show the agency issued 1,033 warning letters, compared with 1,532 for the most recent equivalent period under former President Barack Obama. Compared with the start of the Obama presidency, Trump-era letters dropped by nearly half. Warnings from the FDA Center for Devices and Radiological Health, which helps ensure the safety and quality of medical devices, and from some of the agency’s district offices—including Philadelphia, Florida, and New York—have dropped even more steeply, by more than two-thirds. Two district offices have not issued a warning in more than 2 years. The numbers don’t just reflect a new administration’s slow start. FDA sent significantly fewer warning letters in the second year of Trump’s presidency than in his first.

Charles Piller further reported for Science that:

“Several other FDA actions under Trump show similar declines when measured against the end of the Obama administration. FDA inspection reports labeled ‘official action indicated’—typically a trigger for warning letters or similar actions—have fallen by about half under Trump and are continuing to trend downward. Even FDA’s rare injunctions, a more forceful step than warnings to prevent sales or distribution of unsafe or otherwise illegal products, fell from 35 in the last part of the Obama administration to 26 under Trump. (During a comparable period at the start of the Obama years, FDA issued 51 injunctions.) The agency’s ‘untitled letters’—for concerns that fall short of thresholds for formal warnings—also have dropped sharply under Trump.”

Piller quotes agency critics, including those representing patient and consumer advocacy groups, in their concern that the FDA is signaling Big Pharma and medical device makers that they will receive less oversight in an administration that has boasted about its receptiveness to business interests and which has appointed lobbyists and industry executives to top posts in regulatory agencies. Peter Lurie, an FDA executive under Obama and Trump and now executive director of the Center for Science in the Public Interest, a Washington, D.C., advocacy group, told Piller: “Industry may well take the message from [data showing lessened FDA activity] that the cop is not on the beat as often.”

The FDA, however, denied that it has curtailed its work or that it has become an industry push-over. Instead, its leaders say they are working quietly with Big Pharma and medical device makers with the power of persuasion to address issues that might affect public safety or well-being. Scott Gottlieb, the former FDA commissioner, told Piller: “I don’t think you can paint us with a political narrative—that just because we were a Republican administration, somehow we must have ratcheted down enforcement activity. We didn’t.”

Revolving door oversight

But Gottlieb himself has come under new fire from Elizabeth Warren, the Massachusetts senator and Democratic presidential candidate. She has assailed him for leaping three months after he left the FDA to join the board of Pfizer, receiving $300,000 in compensation in stock and cash for doing so. As the New York Times reported, “Pfizer is one of the nation’s largest drug makers, with blockbuster products like Lipitor and billions of dollars in sales dependent on FDA decisions.”

Although federal law bars Gottlieb from lobbying his former agency for a year or representing any client in business before it or the federal Health and Human Services department, Warren said his new corporate role reflects poorly on him and his government service, enriching Gottlieb in a “revolving door” between a key political post and the corporate board room.

She noted that Gottlieb’s move follows quickly an action by John F. Kelly, the former Secretary of Homeland Security and White House chief of staff. As Warren told the New York Times: “John Kelly helped lead the Trump administration’s ‘zero-tolerance’ immigration policy that led to forcibly separating thousands of migrant children from their parents. Shortly after leaving government, General Kelly joined the board of Caliburn, Inc., the parent company of Comprehensive Health Services, which runs the Homestead Temporary Shelter for Unaccompanied Children in Florida.”

Gottlieb declined to discuss much his Pfizer board seat, saying he respects Warren and worked well with her. He said he would answer her in private with a letter.

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 has become a tough task due to the soaring cost, complexity, and uncertainty of treatments and prescription medications, too many of which prove to be dangerous drugs. Patients, already ill or injured, are vulnerable, and, as taxpayers, they deserve the best from government agencies like the FDA.

‘Emergency’ drug reviews become routine

The Wall Street Journal reported that the agency has made “emergency” drug approvals routine, faster, and based on skimpier evidence. The FDA and its supporters say this has expedited potentially life changing and saving therapies, particularly for cancer, to patients to their benefit. But the swifter oversight also exposes patients to heightened risk and daunting uncertainties about costly drugs, critics say, adding that the agency is giving short shrift to careful science and consumer protection. With little data from FDA watchdogs to base medical decision making on, patients and doctors must make fraught life and death decisions.

This is not good, and it undercuts the reason why taxpayers budgeted more than $3 billion for the FDA in fiscal 2019. We expect the agency to protect us, not to be captives or patsies for Big Pharma, medical device makers, and others the FDA regulates. It is worth noting, however, that the same pro-industry folks who seem so honey-tongued in their dealings with the agency provide it with $2.5 billion in fees for its services like deciding whether drugs and medical devices are safe enough to get to markets.

But, hey, shouldn’t expectations be high for folks for which we fork out $5.5 billion annually? Does the FDA have the right staff in the right numbers and skills to chase down Big Pharma and medical device makers? These are suitable questions for the Congress to demand answers to, and for which the administration soon will face voters about.

The public can make its own decisions about Warren. But she’s dead to rights about the smell test and Gottlieb’s new gig. The good doctor likes to see himself, as he has shown on social media, as an advocate for patients and taxpayers. But he’s tarnishing his reputation, putting himself at risk of he and his agency getting lumped in with notorious Trump appointees like: Tom Price, the high-flying HHS secretary who had his wings clipped when taxpayers found out about his luxe travels at public expense; or Brenda Fitzgerald, a rich doctor who not only wouldn’t pull her hand out of her personal cookie jar of investments and instead plunged it even deeper during her conflicted and brief time as head of the Centers for Disease Control and Prevention.

The 2020 elections get nearer by the day and voters may serve themselves well by remembering how well health agencies and their appointed leaders functioned on their behalf as they head to the polls to pick the president and members of Congress.

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