Tag Archives: FDA

Biden’s Drug Agency Nominee Returns With Deeper Industry Ties

Alex Ruoff, Jeannie Baumann and Celine Castronuovo, Bloomberg Business: November 23, 2021


President Joe Biden’s choice to lead the Food and Drug Administration made millions of dollars from health and drug companies since his last stint in government, raising new questions about his ties to firms the agency oversees.

Robert Califf was paid $2.7 million by Verily Life Sciences, the biomedical research organization operated by Alphabet Inc., and sits on the boards of two pharmaceutical companies, AmyriAD and Centessa Pharmaceuticals PLC. He also reported ties to 16 other research organizations and biotech companies, ethics and financial disclosure documents show.

Califf’s deep industry ties have prompted at least two Democratic senators to oppose his nomination, complicating his path to confirmation and echoing concerns that emerged when he was last nominated. While Califf previously was paid largely as a consultant for drugmakers before, in recent years he’s been hired as a top adviser and board member to major health-care companies creating innovative technologies and medicines.

[….]

Consulting, Stock Options

Califf’s reported income from the health industry skyrocketed between stints at the FDA.

Califf was a paid consultant for Johnson & JohnsonGlaxoSmithKline PLCAstraZeneca PLC, and Eli Lilly from 2009 to 2016, according to disclosures compiled by ProPublica. During this time he collected fees ranging from $2,160 to $9,000. Califf had also disclosed accepting consulting fees from drugmakers Amgen Inc.Eli Lilly & Co., and Merck & Co.

After his time leading the FDA, Califf earned $56,299 in fees from the biopharmaceutical firm Cytokinestics Inc. and unvested stock options worth as much as $5 million from Centessa Pharmaceuticals.

Califf is an expert in clinical trial research and cardiovascular medicine and founded the Duke Clinical Research Institute, a large academic center that received more than half its funding from the drug industry.

This kind of expertise is almost impossible to acquire without working with or for the pharmaceutical industry, David Magnus, director Stanford Center for Biomedical Ethics, said. Drugmakers have historically provided the funding for most clinical trials, he said.

[….]

During his first tour at the FDA, Califf kept a whiteboard in his office that listed all the activities and projects that required his recusal, Howard Sklamberg, who was a deputy commissioner under Califf, said.

“He was very, very, very careful,” Sklamberg, who’s now an attorney at Arnold & Porter LLP, said.

He may have more ties to track this time.

“It seems he would have to recuse himself from a large number of decisions,” Lisa Bero, chief scientist for the University of Colorado Center for Bioethics and Humanities, said.

Califf’s years of ties to the pharmaceutical industry don’t seem to have been “a deciding factor” in the White House’s nomination decision, Diana Zuckerman, president of the National Center for Health Research, said in an interview with Bloomberg Law.

“Dr. Califf has these other very important, positive attributes of having been FDA commissioner, having been a high-level person at FDA even before he was commissioner, and having a track record of showing his commitment to scientific evidence,” Zuckerman said.

The plan offered by Califf to manage his financial interest appears to fairly standard and routine, New York University bioethicist Arthur Caplan said. “I don’t find it disqualifying that he has industry ties,” he said, adding that he’s breaking ties with for-profit, academia, and other think tank types of organizations. Califf “showed himself to be independent and fair” when he was last at the agency, Caplan said.

To read the entire article, click here.

Biden to Choose Robert Califf to Lead F.D.A., Despite Drug Industry Ties

Sheryl Gay Stolberg and Sheila Kaplan, The New York Times: November 12, 2021


WASHINGTON — President Biden on Friday is expected to nominate Dr. Robert M. Califf, a former commissioner of the Food and Drug Administration, to lead the agency again, several people familiar with the planning said. The move would end nearly a year of political wrangling as the White House vetted then dropped several candidates after complaints that some were too close to the pharmaceutical industry.

In the end, White House officials might have concluded that they could not find a suitable candidate with no industry ties. Dr. Califf, 70, a respected academic and clinical trial researcher who ran the agency during the last year of the Obama administration, has long been a consultant to drug companies and ran a research center at Duke University that received some funding from the drug industry.

During his previous stint as commissioner, Dr. Califf sought to permit pharmaceutical companies to advertise off-label uses for F.D.A.-approved products, a practice that is not permitted under the strict regulations governing drug advertising. But the proposal, which many public health experts considered dangerous, was blocked by others in the Obama administration, according to a person familiar with it.

A cardiologist who has seen the harmful effects of smoking on the heart, Dr. Califf has been a forceful advocate for tobacco control; before he was the F.D.A. commissioner, he was the agency’s deputy commissioner for medical products and tobacco. In an appearance with other former commissioners this year, he said, “I have never seen more capable or nastier lawyers than what I experienced in trying to deal with the tobacco industry.”

He added, “It was awesome and quite frightening for public health.”

For the past two years, after stepping down as the vice chancellor for clinical and translational health at Duke University, Dr. Califf has worked as senior adviser to Verily Life Sciences, a health technology firm, and its sister company Google Health. He has encouraged Verily to focus on addiction, cardiovascular health and management of chronic diseases, according to a person at the company who spoke on the condition of anonymity.

[….]

Dr. Califf’s relationships with pharmaceutical companies as a clinical trials researcher proved to be a liability during his Senate confirmation process in 2016. Mr. Manchin blasted him for “big pharma ties” and voted against him.

Dr. Califf was confirmed for the job in a vote of 89 to 4; in addition to Mr. Manchin, Senators Edward J. Markey, Democrat of Massachusetts; Richard Blumenthal, Democrat of Connecticut; and Kelly Ayotte, Republican of New Hampshire, voted against him. But other Republicans, led by Senator Mitch McConnell of Kentucky, then the majority leader, voted in favor.

That support may be one reason Mr. Biden picked Mr. Califf: His selection drew mixed reaction.

“It is surprising that the White House has seemed really tone-deaf on conflicts of interest and very close ties to the industry,” said Diana Zuckerman, the president of the National Center for Health Research, a nonprofit think tank.

But others said they believed that Dr. Califf’s industry experience should not bar him from the job, noting that he has disclosed his ties in publishing the results of clinical trials.

“The truth of the matter is industry develops drugs — you have to work with industry. The issue is disclosure in publication,” said Ellen V. Sigal, the founder and chairwoman of the nonprofit Friends of Cancer Research, which accepts industry funding. “Rob has done many, many clinical trials with industry, but he has not been a pawn of industry. He’s completely committed to transparency, integrity and science.”

[….]

But Dr. [Aaron] Kesselheim objected to Dr. Califf’s efforts, when he was the commissioner, to allow drug companies to advertise off-label uses for their products, noting that patients can be endangered by drugs that are prescribed for uses that the F.D.A. has not approved. “That to me is a red flag,” Dr. Kesselheim said. “Hopefully, he’s moved past that as an idea, because it would be a terrible idea.”

[….]

To read the entire article, click here.

Biden picks ex-FDA chief Robert Califf to again lead agency

Matthew Perrone and Zeke Miller, AP News: November 12, 2021


WASHINGTON (AP) — President Joe Biden on Friday is tapping Dr. Robert Califf, a former Food and Drug Administration commissioner, to again lead the powerful regulatory agency, according to a person familiar with the decision.

Califf’s nomination comes after months of the concern that the agency near the center of the government’s COVID-19 response has lacked a permanent leader. More than a half-dozen names were floated for the job before the White House settled on Califf.

Biden is to make the formal announcement later Friday, said the person familiar, who spoke on the condition of anonymity to preview the announcement.

A cardiologist and clinical trial specialist, Califf, 70, served as FDA commissioner for the last 11 months of President Barack Obama’s second term. Before that, he spent one year as the agency’s No. 2 official after more than 35 years as a prominent researcher at Duke University, where he helped design studies for many of the world’s biggest drugmakers.

Since leaving the government, he has worked as a policy adviser to tech giant Google, in addition to his ongoing academic work at Duke.

[….]

Califf arrived at the FDA in 2015 determined to modernize how the agency reviewed drug and device study data. But his brief time as commissioner was dominated by unrelated pharmaceutical controversies, including the surging epidemic of opioid addiction and overdoses.

He was among the first FDA officials to publicly acknowledge missteps in the agency’s oversight of painkillers like OxyContin, which is widely blamed for sparking the ongoing opioid epidemic, now driven by heroin and fentanyl.

“If addiction to opioids and misuse of opioids is an enemy then we at the FDA — like every other part of society — underestimated the tenacity of the enemy,” Califf told The Associated Press in a 2016 interview. “So we’ve got to adjust.”

Califf’s extensive work with the drug industry drew scrutiny during his Senate confirmation hearing, though he was ultimately confirmed by an overwhelming margin. Given the pressing need for a permanent commissioner, he is expected to again win bipartisan confirmation. He also has the backing of the powerful pharmaceutical and medical device lobbying groups in Washington.

[….]

FDA watchers said Califf had several key advantages over other candidates vetted for the job, several of whom would have faced more scrutiny in the Senate.

“He knows how the FDA works, and he avoided making any outrageous decisions as commissioner,” said Diana Zuckerman of the non-profit National Center for Health Research. “Those are essential if the FDA is going to regain the public trust.”

His first tasks would include easing burnout and boosting morale among the FDA’s 18,000 employees. The agency’s medical reviewers have been straining for months under a crushing coronavirus pandemic workload, while the agency’s reputation for scientific independence has been battered by a string of public controversies.

Two congressional committees are investigating the agency’s June approval of the much-debated Alzheimer’s drug Aduhelm against the recommendation of its outside experts, three of whom resigned over the decision. Then in September, two top FDA vaccine regulators announced they would leave the agency after disagreeing with the Biden administration plan to make COVID-19 vaccines boosters widely available.

[….]

To read the entire article, click here.

Biden expected to tap Califf as FDA commissioner

Emily Kopp, Roll Call: November 12, 2021


President Joe Biden is expected to tap Robert Califf to again serve as commissioner of the Food and Drug Administration.

Califf, who previously helmed the FDA in the final year of the Obama administration, is seen as a status quo choice.

Independent experts say Califf has decades of experience in the development and conduct of clinical trials. That resume has brought Califf in frequent contact with both the FDA and the pharmaceutical industry he would be charged with regulating.

[….]

Califf had such strong bipartisan support that when Trump took office in early 2017, many pharmaceutical and medical device industry officials expressed hope he would continue on as the FDA’s leader.

“My feeling about Califf is that he’s a political compromise. His nomination shows the power of pharma. But despite his close ties to pharma, he has always talked about the importance of solid scientific evidence.” said Diana Zuckerman, president of the National Center for Health Research, a think tank in Washington, D.C. “I have some confidence that Dr. Califf is not someone who likes controversy. That is different than Dr. Woodcock who doesn’t seem to mind controversy at all. I’m hopeful he will really focus on the science in a way that has been missing lately at FDA.”

Califf’s background

Califf is a longtime cardiologist and a professor in the school of medicine at Duke University. Califf also served as founding director of the Duke Clinical Research Institute, a partnership between the university and pharmaceutical companies with the goal of innovating clinical trial design. He led it for a decade. The research institute receives about half of its funding from the pharmaceutical industry and half from the government, according to a 2020 report. He founded the Clinical Trials Transformation Initiative, a collaboration between the FDA and Duke on improving the speed and reducing the cost of clinical trials, which collaborates with pharmaceutical companies.

Califf is also an executive at Verily Life Sciences, formerly Google Life Sciences, an Alphabet Inc. company.

[….]

But Califf has in several public statements voiced support for more patient input at the FDA.

Critics say this advocacy is often financed by the pharmaceutical industry, and the FDA often does not distinguish between authentic advocacy and these conflicts of interest.

Califf has also called for other changes to clinical trials supported by the pharmaceutical company, including greater reliance on real-world evidence pulled from electronic health records outside of a clinical trial and on biomarkers, biological signals a drug is working before it shows a clinical benefit.

“Of course, the devil’s always in the details. It’s fine to be supportive, for example, of biomarkers as a way to get information about potential benefits but it needs to be backed up by solid science,” said Zuckerman.

At the FDA, Califf would likely have to respond to an ongoing investigation by the Health and Human Services inspector general into the approval of the Alzheimer’s drug aducanumab. It was approved through FDA’s accelerated approval pathway based on the difference it made with a controversial biomarker, amyloid plaques.

[….]

To read the entire article, click here.

Biden chooses Robert Califf, former Obama FDA chief, as agency commissioner

Laurie McGinley, Washington Post: November 12, 2021


President Biden is expected Friday to nominate former Food and Drug Administration commissioner Robert M. Califf to return as the agency’s head, ending a difficult, months-long search to find a leader for the sprawling bureaucracy on the front lines of the coronavirus pandemic.

The announcement is expected later in the day, according to people familiar with the decision who spoke on the condition of anonymity because they were not authorized to discuss the issue.

Califf, 70, a renowned cardiologist and researcher, is senior adviser for Verily, a research organization devoted to the life sciences, and Google Health. He served as FDA commissioner during the last year of the Obama administration. Before that, he had a long career at Duke University School of Medicine, where he founded the Duke Clinical Research Institute, one of the largest academic clinical trial operations in the world.

Many FDA experts see Califf as a safe choice — an experienced hand who is unlikely to make abrupt changes as the agency navigates a tumultuous period marked by high-pressure reviews of coronavirus vaccines and therapies and hot-button issues involving Alzheimer’s treatments, opioids and tobacco products. An expert on clinical trials and other types of health data, Califf is likely to press for better evidence in assessing drugs and devices.

But others hoping for fresh leadership see Califf’s nomination as a missed opportunity. Some are uncomfortable with his longtime relationships with the pharmaceutical industry.

[….]

“I think he would be terrific,” said Harlan Krumholz, a cardiologist at Yale School of Medicine. “It is critically important to have a commissioner who can step in and knows the job and knows how to make policy decisions.”

Even some of the agency’s toughest critics say Califf is acceptable.

“Rob Califf is a good choice,” said Aaron S. Kesselheim, a professor of medicine at Harvard Medical School who has faulted the FDA for approving drugs on what he considers flimsy evidence. “Califf certainly spent the vast majority of his early career working on clinical trials … and understands the value of rigorous data.”

But Califf’s longtime industry relationships have drawn criticism from some who argue the agency already is too close to the companies it regulates.

“Califf has a long history of extensive financial ties to Big Pharma, most significantly through pharmaceutical industry funding of the Duke Clinical Research Institute,” said Michael Carome, director of nonprofit Public Citizen’s Health Research Group, a consumer advocacy organization. “We need someone to tilt in the opposite direction and be more pro-public health and less pro-regulated industry.”

Some past critics, however, have softened their views of Califf. Diana Zuckerman, president of the National Center for Health Research, a nonprofit think tank, said that while she still considers Califf’s industry ties to be a shortcoming, “He has certain qualities that are very good for the position. He has experience at the FDA and a commitment to science. That’s very important.”

 [….]

 To read the entire article click here.

Breast Implants will now come with Black Box Warnings, List Risks

Sara E. Teller, Legal Reader: November 9, 2021


In 2019, a Food and Drug Administration (FDA) panel heard from dozens of women asking the government agency to inform the public in a direct way about the debilitating and potentially life-threatening symptoms commonly referred to as “breast implant illness.”  Now, ten years after discovering a link between some implants and cancer, the FDA has ordered “black box” warnings be put on all boxes and a new checklist of risks to be provided to patients.

The warnings and checklist advise patients of the serious side effects, including the link to cancer of the immune system (anaplastic large cell lymphoma), as well as chronic medical conditions, including autoimmune diseases, joint pain, mental confusion, muscle aches and chronic fatigue.  The checklist even identifies which types of patients could be at higher risk for illness after breast implant surgery.  And this includes breast cancer patients who have had, or plan to have, chemotherapy or radiation treatments – the very same population of women who are commonly encouraged to seek implants for breast reconstruction.

The FDA is also requiring manufacturers to disclose the ingredients used to make implants, and these must be made public within thirty days.  However, one complication is that patients are unlikely to see a warning label on sterile medical device only a surgeon would have access to.  It’s also not clear how the new mechanisms will be reinforced, even though the FDA said all patients “must be given the opportunity to sign the checklist.”

Critics of the checklist have said that the language used is hard to understand and that patients may sign off without fully understanding what they’re signing. “It’s better than nothing, but it’s not as good as it could be,” said Diana Zuckerman, a scientist at the National Center for Health Research and member of the working group that advised the FDA on implant safety. “They say things like, ‘Breast implants are associated with lymphoma,’ but lymphoma is actually caused by the implants.  People understand it if you say, ‘Breast implants can cause lymphoma.’”

She also believes not every surgeon will take the time necessary to allow patients to digest the black box warning information and ask any questions. “What if a surgeon says, ‘Here’s a checklist.  I know it’s long, so it’s up to you if you want to read it or not’?” Dr. Zuckerman said. “Patient groups are very concerned that will happen.”

Dr. Mark Clemens, a professor at M.D. Anderson Cancer Center in Houston and a liaison to the FDA for the American Society of Plastic Surgeons Society, argued, “The black box warning and checklist represent a huge step forward for patient safety and implants.  But more high-quality data about long-term outcomes for women with implants is needed.”

[….]

To read entire article, click here.

Patients Must Be Warned of Breast Implant Risks, F.D.A. Says

Roni Caryn Rabin, The New York Times: October 27, 2021


Federal regulators on Wednesday placed so-called black box warnings on breast implant packaging and told manufacturers to sell the devices only to health providers who review the potential risks with patients before surgery.

Both the warnings and a new checklist that advises patients of the risks and side effects state that breast implants have been linked to a cancer of the immune system and to a host of other chronic medical conditions, including autoimmune diseases, joint pain, mental confusion, muscle aches and chronic fatigue.

Startlingly, the checklist identifies particular types of patients who are at higher risk for illness after breast implant surgery. The group includes breast cancer patients who have had, or plan to have, chemotherapy or radiation treatments.

That represents a large percentage of women who until now were encouraged to have breast reconstruction with implants following their treatment.

The Food and Drug Administration is also requiring manufacturers for the first time to disclose the ingredients used to make breast implants, information that patient advocates have long sought. The information must be made public in 30 days.

It is not clear how the new requirements will be enforced, and patients are highly unlikely to ever see a warning label on a packaged sterile medical device that is usually handled only by a surgeon. F.D.A. officials said in a statement that the patients “must be given the opportunity” to sign the checklist.

[….]

Reactions to the new requirements were mixed. While some doctors welcomed the new warning system, others worried that the potential risks and side effects would not be conveyed adequately by plastic surgeons who were eager to reassure patients the procedure is safe and that the new checklist would be handled in a dismissive manner.

Critics also said the checklist was overly long and written in obtuse language. “It’s better than nothing, but it’s not as good as it could be,” said Diana Zuckerman, a scientist who heads the National Center for Health Research and was a member of the working group that advised the F.D.A. on implant safety.

“They say things like, ‘Breast implants are associated with lymphoma,’ but lymphoma is actually caused by the implants,” Dr. Zuckerman said. “People understand it if you say, ‘Breast implants can cause lymphoma.’”

She worried that surgeons would not take the time to adequately review the information with patients.

“What if a surgeon says, ‘Here’s a checklist — I know it’s long, so it’s up to you if you want to read it or not’?” Dr. Zuckerman said. “Patient groups are very concerned that will happen.”

[….]

To read the entire article, click here.

Covid-19: FDA set to grant full approval to Pfizer vaccine without public discussion of data

Gareth Iacobucci, BMJ: August 20, 2021


Transparency advocates have criticised the US Food and Drug Administration’s (FDA) decision not to hold a formal advisory committee meeting to discuss Pfizer’s application for full approval of its covid-19 vaccine.

Last year the FDA said it was “committed to use an advisory committee composed of independent experts to ensure deliberations about authorisation or licensure are transparent for the public.”1 But in a statement, the FDA told The BMJ that it did not believe a meeting was necessary ahead of the expected granting of full approval.

“The FDA has held numerous meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) related to covid-19 vaccines, including a 22 October 20202 meeting to discuss, in general, the development, authorisation, and licensure of covid-19 vaccines,” an FDA spokesperson said.

“The FDA also has held meetings of the VRBPAC on all three covid-19 vaccines authorised for emergency use and does not believe a meeting is needed related to this biologics license application.”

The spokesperson added, “The Pfizer BioNTech covid-19 vaccine was discussed at the VRBPAC meeting on 10 December 2020.3 If the agency had any questions or concerns that required input from the advisory committee members we would have scheduled a meeting to discuss.”

The vaccine has already been rolled out to millions of Americans through an emergency use authorisation. Companies typically apply for full approval after a longer period has elapsed so that more data are available for review.

But with the US government indicating this week that it plans to start making booster shots widely available next month, experts said the decision not to meet to discuss the data was politically driven.

Data scrutiny

 Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee,4 said the decision removed an important mechanism for scrutinising the data.

“These public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under emergency use authorisation,” she said. “The public deserves a transparent process, especially as the call for boosters and mandates are rapidly increasing. These meetings offer a platform where questions can be raised, problems tackled, and data scrutinised in advance of an approval.”

[….]

Public discussion

Diana Zuckerman, president of the National Center for Health Research, who has also spoken at recent VRBPAC meetings, told The BMJ, “It’s obvious that the FDA has no intention of hearing anyone else’s opinion. But if you make decisions behind closed doors it can feed into hesitancy. It’s important to have a public discussion about what kind of data are there and what the limitations are. As we think about risk versus benefit, we need to know.”

Joshua Sharfstein, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health and former FDA deputy commissioner during the Obama administration, said that advisory committee meetings were more than just a way of receiving scientific input from outside experts. “It’s also an opportunity to educate the public about the important work that the FDA has done reviewing an enormous amount of data about a product,” he told The BMJ. “It’s a chance for questions to be asked and answered, building public confidence. If there are no advisory committee meetings prior to licensure, the FDA should consider taking extra steps to explain the basis of its decisions to the public.”

[….]

To read the entire article, click here https://www.bmj.com/content/374/bmj.n2086

Beleaguered FDA in talks for drug-company funding

Eleanor Laise, Marketplace: July 13, 2021


Fees paid by drug and device makers influence agency operations at the expense of patient safety, critics say.

Amid a firestorm over its approval of a new Alzheimer’s treatment, the Food and Drug Administration is holding closed-door meetings with companies it regulates — talks that critics say allow drug and device makers to exert outsize influence over the agency’s operations, threatening to erode public trust in the agency at a critical moment.

The talks focus on “user fees” that pharmaceutical and medical-device companies pay to the FDA annually and when applying for approval of new products. The FDA in recent years has become increasingly reliant on such payments, which funded nearly half of the agency’s total spending in fiscal year 2020. In exchange for the fees, the FDA agrees to certain deadlines for reviewing new-product applications, the type and frequency of meetings with companies submitting applications, and other commitments. The medical-product user-fee agreements are generally renegotiated every five years — a process that’s happening now, in advance of the current agreements’ expiration next year — and submitted to Congress for authorization.

Although the FDA is required by law to consult with patient and consumer advocacy groups on the discussions and make minutes of its industry meetings public, the meat of the talks often remains hidden, observers say. Since September of last year, the FDA has held more than 150 meetings with industry to discuss fee agreements for brand-name prescription drugs, generics, medical devices and biosimilars (products similar to branded biologic drugs), which together are expected to generate nearly $2 billion for the agency this fiscal year. Yet consumer advocates and other outside groups attempting to track the discussions say they remain in the dark about most of the details. FDA summaries of some recent meetings have been posted months after the fact or sum up a discussion in a single sentence. Medical-product safety experts say they’ve repeatedly asked for more access and details on the negotiations, to no avail.

“We simply can’t get a view into this process, and the lack of transparency is deliberate,” says Madris Kinard, a former public health analyst at the FDA and CEO of Device Events, which tracks medical-device adverse-event reports.

Details about the negotiations that have trickled out raise alarms among some medical-product safety experts, academic researchers and consumer advocates that the industry’s leverage in these talks ultimately puts patients at risk. User fees are speeding more products to market without a corresponding increase in resources to track the safety of those products, critics say. Yet in the current round of negotiations, FDA efforts to allocate more user fees toward monitoring the safety of medical products already on the market have met industry resistance.

[….]

The main idea behind the user-fee programs was to speed up FDA review of medical-product marketing applications — and they’ve delivered on that front. The median time to approval for standard new-drug applications was 10 months in fiscal 2018. In the years before user fees were first enacted, the median FDA application review time was nearly three years, according to a study by Kesselheim and colleagues at Harvard and Brigham and Women’s Hospital.

[….]

But user-fee deadlines can have serious side effects, some experts say. As the opioid crisis was exploding, “there was a question of ‘Why does the FDA keep approving the opioids?’ ” says a former FDA official. “One reason was that they had applications and had user-fee obligations to review the applications.” So long as an application met the standard requirements, “it would be approved,” he says. “That’s an example of the mindset” created by the deadlines.

Several studies have linked faster drug-approval timelines to safety issues. A 2014 study in Health Affairs found that drugs approved after user fees were enacted were more likely to get new black-box warnings or be withdrawn from the market than drugs approved in the pre-user-fee era. Other studies have found that, compared with drugs approved at other times, drugs given the green light shortly before their user-fee deadlines were more likely to have subsequent safety issues.

[….]

In the current round of medical-device user-fee negotiations, one of the FDA’s goals is to improve device safety, including through increased funding for surveillance of devices already on the market, the agency says. That proposal met stiff resistance from the industry, according to outside groups that have received FDA briefings on the talks. At an April 7 negotiation meeting, the industry expressed the view that fees “should be solely for the premarket review process,” according to a summary posted by FDA. Medical-device trade group AdvaMed didn’t respond to requests for comment.

At the start of the prescription-drug user-fee negotiations, the FDA also emphasized its hope of improving the Sentinel Initiative, a system for assessing the safety of approved medical products. But a related proposal advanced by the FDA during the negotiations was shot down by the industry, a December meeting summary notes.  

[….]

Revolving doors

“There’s not a lot of friction between the industry and the agency” in prescription-drug user-fee negotiations, says a former FDA official. “The industry knows it’s getting good value.”

A sign of the amicable relations: One FDA official leading the current round of prescription-drug user-fee negotiations left the agency in April of this year, according to her LinkedIn profile, to become vice president of science and regulatory affairs at BIO — one of the industry groups she’d just been negotiating with. The former FDA official, Khushboo Sharma, participated in a user-fee negotiation meeting with BIO and other industry representatives as recently as Feb. 12, according to meeting summaries posted by the agency. “That is obviously an outrageous situation and clearly undermines the integrity” of the process, says Diana Zuckerman, president of the National Center for Health Research, a nonprofit think tank.

Asked for comment, the FDA sent a link to its post-employment restrictions, which say in part that current employees who have begun seeking employment outside the federal government must immediately recuse from certain matters that affect “the discrete industry, economic sector, or other defined class of organizations in which the prospective employer operates.” BIO didn’t respond to a request for comment. Sharma says that she worked with FDA ethics officials “to ensure I was recusing myself from all appropriate activities. I started seeking post-employment opportunities after negotiations had concluded.”

When the agency’s position does conflict with an industry’s, the FDA “is not going to come out on top,” says Lisa McGiffert, a patient-safety advocate at the nonprofit Patient Safety Action Network. Given the industry’s track record of snagging many items on its wish list, some observers are concerned that the current round of negotiations could chip away at FDA standards for approving new drugs. One issue: the use of “real-world data,” which can come from insurance claims, medical records, disease registries and other sources beyond the bounds of clinical trials. In an August 2020 letter to the FDA about user-fee reauthorization, PhRMA said that real-world data and evidence “may, in some circumstances, be adequate on their own to satisfy the substantial evidence criteria for demonstrating effectiveness” of drugs.

[….]

To read the entire article, click here.