Tag Archives: FDA

Emergency Use Authorization vs. Full Approval: What are the Implications?

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Laurie Saloman, Contagion Live: June 20, 2021

Emergency use authorizations, or EUAs, have gotten a lot of attention during the COVID-19 pandemic. The concept of the U.S. Food and Drug Association (FDA) authorizing a product or treatment quickly and without going through a full and complete review process was first introduced in 2005. At that time, the FDA issued an EUA for an anthrax vaccine available to military personnel due to a spate of anthrax-laced letters that killed or sickened nearly 2 dozen people.

Over the following years, EUAs were issued for a variety of experimental therapies for diseases such as H1N1 (swine flu), Middle East Respiratory Syndrome (MERS), Ebola, and Zika, which often arose quickly and threatened to become bona fide pandemics. Since last year, numerous EUAs have been issued for COVID-19-related products, including diagnostic and antibody tests, clinical treatments, and vaccines.

But what does it actually mean when a product is given an EUA, and why don’t companies automatically seek full FDA approval? According to Diana Zuckerman, PhD, president of the National Center for Health Research, there are several reasons why a company might not pursue approval for a product.

“One [reason] is that it’s found to not work, and so no effort is made to get it approved, and the other is that the company doesn’t necessarily have the incentive to do the research that they would need to do in order to get it approved, because the standards for an EUA are always lower than the standards would be for FDA approval,” she said. “If FDA approval would require a bigger, longer-term study with more patients, that just may not be worth it.” She offered the example of EUAs for various therapies for the Ebola virus, which does not currently present a threat to the US.

Even if a company wants to receive full approval for a product, it can run into problems if it can’t find enough of a patient population to participate in large-scale trials, added Susan Wood, PhD, professor of Health Policy and of Environmental and Occupational Health at the George Washington University Milken Institute School of Public Health and the former Assistant Commissioner for Women’s Health at the FDA.

Zuckerman and Wood agreed that, ideally, companies producing therapies that receive EUAs would go on to pursue approval for these therapies, especially as approved therapies can sometimes be repurposed to work for conditions other than those for which they were initially intended. “The reason why we were able to move…quickly with Covid was because of the work that had been done with other coronaviruses previously, and that really set the stage,” Zuckerman said. “Whether it’s for a rare disease or a future pandemic that we can’t predict, yes, having more information now can help us later.”

For companies, having full approval provides a measure of control. The FDA can withdraw an EUA at any time, preventing a company from selling or dispensing their product; in contrast, it can take several years for the agency to rescind an approval. Insurance typically doesn’t pay for products under an EUA, although in the case of Covid-19 vaccines the government is footing the bill, possibly making financial motives less of a factor for pharmaceutical companies.

But while EUAs are designed to help people get immediate assistance, it’s not uncommon for tests or therapies granted EUAs to end up being ineffective. In the case of COVID-19 tests and treatments, the FDA issued EUAs it later revoked. For example, in March of 2020, companies were permitted to sell antibody tests—which purported to tell users whether or not they had COVID-19 in the past—without submitting EUA applications. In May of 2020, companies were allowed to sell COVID-19 diagnostic tests for 15 business days before they had to submit EUA applications. During that month, the FDA issued 84 EUAs for various labs and companies, and there were an additional 400 applications pending review.

But by February of 2021, enough data on testing had been collected for the FDA to reject 225 different antibody tests. Similarly, although the FDA had granted EUA status to the drug hydroxychloroquine in March of 2020, by June of 2020 it was clear from studies that the drug not only had no discernible benefit but might even be harmful to Covid-19 patients, and the EUA was withdrawn in June 2020.

The lack of full approval by the FDA has been cited as a factor in the reluctance of some people to get the Covid-19 vaccine and has emerged as a flashpoint in the fight over vaccine mandates. Typically, mandates come after years of experience with a vaccine. “Normally…the testing is slower, the back and forth between the FDA and companies is slower, the review process is slower, and it comes on the market in a graduated fashion,” Wood said. At that point, there’s much more acceptance by the general population. “Now, everything’s been compressed, including EUA, and we’re moving straight into mandates by businesses.”

Read the original article here.

To Stay: Two More Cancer Indications With ‘Dangling Approvals’

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Kerry Dooley Young, Medscape News: April 29, 2021

Two more cancer indications that had been granted accelerated approval by the US Food and Drug Administration (FDA) are going to stay in place, at least for now. This was the verdict after the second day of a historic 3-day meeting (April 27–29) and follows a similar verdict from day one.

Federal advisers so far have supported the idea of maintaining conditional approvals of some cancer indications for a number of immunotherapy checkpoint inhibitors, despite poor results in studies that were meant to confirm the benefit of these medicines for certain patients.

On the second day (April 28) of the 3-day FDA meeting, the Oncologic Drugs Advisory Committee (ODAC) supported the views of pharmaceutical companies in two more cases of what top agency staff call “dangling accelerated approvals.”

ODAC voted 10-1 in favor of maintaining the indication for atezolizumab (Tecentriq) for the first-line treatment of cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma, pending final overall survival results from the IMvigor130 trial.

ODAC also voted 5-3 that day in favor of maintaining accelerated approval for pembrolizumab (Keytruda) for first-line cisplatin- and carboplatin-ineligible patients with advanced/metastatic urothelial carcinoma.

The FDA often follows the advice of its panels, but it is not bound to do so. If the FDA were to decide to strip the indications in question from these PD-1 medicines, such decisions would not remove these drugs from the market. The three drugs have already been approved for a number of other cancer indications.

Off-label prescribing is not uncommon in oncology, but a loss of an approved indication would affect reimbursement for these medicines, Scot Ebbinghaus, MD, vice president of oncology clinical research at Merck & Co (the manufacturer of pembrolizumab), told ODAC members during a discussion.

[….]

Another participant at the meeting asked the panel and the FDA to consider the burden on patients in paying for medicines that have not yet been proven to be beneficial.

Diana Zuckerman, PhD, of the nonprofit National Center for Health Research, noted that the ODAC panel included physicians who see cancer patients.

“You’re used to trying different types of treatments in hopes that something will work,” she said. “Shouldn’t cancer patients be eligible for free treatment in clinical trials instead of paying for treatment that isn’t proven to work?”

[….]

To read the entire article, see https://www.medscape.com/viewarticle/950165

NCHR Statement Regarding Cancer Drugs that Failed to Confirm Efficacy after Accelerated Approval

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April 29, 2021

I’m Dr. Diana Zuckerman, president of the National Center for Health Research.  Our center is a nonprofit think tank that scrutinizes the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products.  Today I’m speaking from my perspective as a scientist who left Harvard more than 30 years ago to come to Washington D.C. to work in the House of Representatives. I worked as a Congressional investigator for the Subcommittee that conducted oversight over all of HHS, and that’s when I first learned about the laws and regulations governing the FDA.  I was responsible for several oversight hearings that attracted enormous media attention, because we found that patients had been harmed when the FDA was not following the law pertaining to FDA approval.

The law is very clear:  Drugs and biologics must be proven safe and effective, and that’s defined as having benefits that outweigh the risks for most patients.  FDA’s memoranda that were provided to this Committee for this meeting and for each of these indications over these last 3 days have made it clear that the data do not support that.  This Advisory Committee has looked at the data, seen reasons for optimism when looking at nonsignificant trends, and recommended that the FDA keep drugs on the market that don’t meet the standard specified by law.  That’s your right to do that, since you are advising the FDA based on your perspectives, experiences, and interpretations of the data.

I want to thank the FDA scientists who carefully analyzed the data and presented their findings.  You did a great job.  I’m here to urge the FDA to follow in your footsteps and follow the law and rescind approval for these indications until the companies complete randomized clinical trials that prove that the benefits outweigh the risks. I especially want to thank Dr. Pazdur for explaining how the FDA’s Expanded Access program can fill in the gaps for patients who need access to these drugs.  The companies agreed to complete confirmatory trials as part of the accelerated approval of their drugs, and I strongly urge the FDA to hold them to it.

All of these companies are leaders in their field and absolutely capable of conducting the research needed to prove whether or not their drugs have benefits that outweigh the risks for the exact specific indications they were previously approved for.  The companies also have the ability to make expanded access quick and easy.  Let’s face it, if they don’t have the expertise and resources to do the studies and help with expanded access, who does?  If the data don’t confirm the initial accelerated approval, the companies should work with the FDA to design trials to narrow the indication to figure out which are the patients most likely to be helped and which are the ones most likely to be harmed.

FDA Scrutinizes Pricey Cancer Drugs

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Politico Pulse: April 28, 2021

What should be done about expensive cancer drugs on the market that might not work? That could be the first thorny question to confront Woodcock, who is acting FDA commissioner while Biden weighs whether to nominate her for the full-time role.

The FDA is convening an expert panel this week to discuss whether the agency should revoke approved uses of three therapies that, despite positive signs from early research, failed to help patients with certain cancers live longer. All three medicines were approved under Woodcock’s tenure as drug chief and after increasingly speedy reviews.

Drug regulators “wanted to get these drugs to market as quickly as possible,” said Diana Zuckerman, a drug safety expert and president of the National Center for Health Research, who is presenting several times at this week’s meeting. “That was clearly their goal and they succeeded in doing it. But now there is a reckoning.”

What the companies say: Genentech, Merck and Bristol-Myers Squibb, the companies at the center of the debate, say their drugs still have value against the cancers in question, they just need to do more research. And Genentech on Tuesday applauded the advisory panel’s vote to keep its drug on the market for triple-negative breast cancer, one of the approvals in question.

To see the entire Politico Pulse, read https://www.politico.com/politicopulse/.

Conflicts Galore: Upcoming Accelerated Approval Cancer Panel May Be Tainted By Industry Relationships

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Sarah Karlin-Smith, Pink Sheet: April 21, 2021

Six members of the FDA Oncologic Drugs Advisory Committee received conflict of interest waivers to participate in the agency’s upcoming three-day meeting to review the accelerated approval of six checkpoint inhibitor indications after the three cancer immunotherapies at issue failed to confirm clinical benefit in post-market trials raising questions about whether industry influence may heavily factor in the committee’s decision making.

The high number of waivers could mean that a majority or close to a majority of the panelists will have conflicts based on the typical number of advisors on FDA panels. The agency used to be subject to waiver limits but the 2012 FDA Safety and Innovation Act removed these restrictions.

ODAC’s 27-29 April meeting, part of the agency’s broader industry-wide effort to evaluate accelerated approvals for oncology drugs, is unprecedented in the number of drugs and indications up for accelerated approval withdrawal. The committee will discuss two indications for Tecentriq (atezolizumab); three for Keytruda (pembrolizumab); and one for Opdivo (nivolumab).

[….]

Vinay Prasad, a hematologist-oncologist at the University of California San Francisco acknowledged that it may not always be easy to find unconflicted experts but, he said they do exist. He also argued that in this case you might be able to look at other professionals like internists who study research methods and FDA approvals, for example for panel members.

[….]

Diana Zuckerman, president of the National Center for Health Research said that while FDA needs some people with clinical expertise who understand the illness and issues with the treatment, it doesn’t need an entire panel of these people. She said that one way FDA can find more qualified experts is by looking at schools of public health where academics rarely get money from industry and they have expertise in understanding clinical trials as well as biostatics.

Even if the academic’s salary isn’t directly funded by their work with industry, there are multiple reasons to be concerned that work on industry trials with the same drugs creates conflicts.

“There’s research showing that researchers feel more positively about drugs that they’ve studied. That’s normal human behavior. You feel proprietary towards something that you’ve studied. You also have a relationship with the company,” said Adrian Fugh-Berman a professor Pharmacology and Physiology at Georgetown where she directs PharmedOut, a project that focuses on evidence-based prescribing and studying industry marketing practices.

The person may also be thinking about how their behavior on the committee may impact other research opportunities the university or they in particular have with the company, she explained.

“Are you going to get more research grants for the company if you kill their drug?” Fugh-Berman said.

[….]

Over the past 12 months ODAC has had two other committee meetings where four waivers were granted but that is far from typical. Most agency advisory committees don’t have any waivers or at most have one or two, per data from FDA from 2018 onward.

FDA is supposed to publish an annual report to Congress on advisory committees that include information on waivers but the latest report available online was from fiscal year 2016. FDA did respond to questions about whether more updated data exists and where it can be found.

​To read the entire article, see https://pink.pharmaintelligence.informa.com/PS144196/Conflicts-Galore-Upcoming-Accelerated-Approval-Cancer-Panel-Includes-Many-Industry-Relationships

Janet Woodcock revolutionized the way the FDA reviews cancer drugs, inspiring her supporters and raising concerns for detractors

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Nicholas Florko, STAT News: March 1, 2021

In 2000, the Food and Drug Administration approved just three cancer drugs. Last year, even with the agency laser-focused on the coronavirus pandemic, much of its staff teleworking, the agency still approved a record-breaking 17 different cancer therapies — more than in any other category. That’s the legacy of FDA drug center chief Janet Woodcock. Woodcock, a 36-year veteran of the agency, is infamous for pushing the FDA to loosen its standards for drugs for rare conditions like Duchenne muscular dystrophy. But Woodcock’s most lasting impact at the FDA is her transformation of the way the agency approaches cancer drug approvals….. Now the nation’s top cancer doctors are emerging as Woodcock’s most vocal backers in her campaign to become President Biden’s FDA commissioner.

Critics say Woodcock’s cancer crusade has come at a cost. With the speed has come an erosion of the agency’s high standards and an increasing willingness to greenlight drugs that haven’t actually been proven to extend a patient’s life. … Their complaint mostly revolves around Woodcock’s willingness to accept studies testing drugs based on so-called surrogate endpoints, measures like the shrinkage of a tumor, rather testing a drug based on how long it keeps a patient alive. ….It’s a view that even some former FDA officials hold; one described Woodcock as pushing “flexibility even at the expense of science.”

[.…]

“For many cancers there is an improvement in survival, the question is which drugs are responsible for that and which ones aren’t, that’s the big unknown and that’s what’s so frustrating,” said Diana Zuckerman, the president of the National Center for Health Research. The end result of this confusion, critics argue, is that doctors and patients are left guessing whether a drug is truly effective, or worth the money.

 [….]

Read the full article here.

J&J COVID-19 Vaccine Wins Unanimous Backing of FDA Panel

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Kerry Dooley Young, Medscape Medical News: February 26, 2021

An FDA advisory panel lent their support today to a rapid clearance for Janssen/Johnson & Johnson’s COVID-19 vaccine.

The Food and Drug Administration (FDA) is expected to quickly provide an emergency use authorization (EUA) for the vaccine following the recommendation by the panel.

The FDA’s Vaccines and Related Biological Products Advisory Committee voted 22-0 on this question: Based on the totality of scientific evidence available, do the benefits of the Johnson & Johnson COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?

The Johnson & Johnson vaccine is expected to offer more convenient dosing and be easier to distribute than the two rival products already available in the United States. Janssen’s vaccine is intended to be given in a single dose. In December, the FDA granted EUAs for the Pfizer/BioNTech and Moderna COVID-19 vaccines, which are each two-dose regimens.

[….]

Weakened Standards?

Several researchers called on the FDA to maintain a critical attitude when assessing Johnson & Johnson’s application for the EUA, warning of a potential for a permanent erosion of agency rules due to hasty action on COVID vaccines.

They raised concerns about the FDA demanding too little in terms of follow-up studies on COVID vaccines and with persisting murkiness resulting in attempts to determine how well these treatments work beyond the initial study period.

“I worry about FDA lowering its approval standards,” said Peter Doshi, PhD, from The BMJ and a faculty member at the University of Maryland School of Medicine in Baltimore, during an open public hearing at the meeting.

“There’s a real urgency to stand back right now and look at the forest here, as well as the trees, and I urge the committee to consider the effects FDA decisions may have on the entire regulatory approval process,” Doshi said.

Doshi asked why Johnson & Johnson did not seek a standard full approval — a biologics license application (BLA) — instead of aiming for the lower bar of an EUA. The FDA already has allowed wide distribution of the Pfizer/BioNTech and Moderna vaccines through EUAs. That removes the sense of urgency that FDA faced last year in his view.

The FDA’s June 2020 guidance on the development of COVID vaccines had asked drug makers to plan on following participants in COVID vaccine trials for “ideally at least one to two years.” Yet people who got placebo in Moderna and Pfizer trials already are being vaccinated, Doshi said. And Johnson & Johnson said in its presentation to the FDA that if the Ad26.COV2.S vaccine were granted an EUA, the COV3001 study design would be amended to “facilitate cross-over of placebo participants in all participating countries to receive one dose of active study vaccine as fast as operationally feasible.”

“I’m nervous about the prospect of there never being a COVID vaccine that meets the FDA’s approval standard” for a BLA instead of the more limited EUA, Doshi said.

Diana Zuckerman, PhD, president of the nonprofit National Center for Health Research, noted that the FDA’s subsequent guidance tailored for EUAs for COVID vaccines “drastically shortened” the follow-up time to a median of 2 months. Zuckerman said that a crossover design would be “a reasonable compromise, but only if the placebo group has at least 6 months of data.” Zuckerman opened her remarks in the open public hearing by saying she had inherited Johnson & Johnson stock, so was speaking at the meeting against her own financial interest.

“As soon as a vaccine is authorized, we start losing the placebo group. If FDA lets that happen, that’s a huge loss for public health and a huge loss of information about how we can all stay safe,” Zuckerman said.

Read the entire article here. 

What you need to know about J&J’s newly authorized one-shot COVID-19 vaccine

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Tina Hesman Saey, ScienceNews: February 27, 2021

And then there were three: A single-shot vaccine is the latest weapon to join the battle against COVID-19 in the United States.

On February 27, the U.S. Food and Drug Administration gave emergency use authorization for Johnson & Johnson’s vaccine against SARS-CoV-2, the coronavirus that causes COVID-19. South Africa is the only other country to OK Johnson & Johnson’s vaccine so far, though other countries are poised to follow suit.

The FDA determined that Johnson & Johnson’s vaccine meets the criteria for safety and effectiveness and that there is clear evidence that it may prevent COVID-19, the agency said in a statement.

“With today’s authorization, we are adding another vaccine in our medical toolbox to fight this virus,” said Peter Marks,  director of the FDA’s Center for Biologics Evaluation and Research.

Its authorization for emergency use in the United States – for people age 18 and older – follows similar authorizations in December for vaccines made by Moderna and by Pfizer and its German partner BioNTech.

[….]

As of February 25, more than 52,000 people were hospitalized in the United States fighting COVID-19, according to the COVID Tracking Project. That’s down from the record-setting daily peaks of more than 130,000 in early January and the lowest since early to mid-November. More than half a million people in the United States have now died from COVID-19.

In Johnson & Johnson’s clinical trial, two of the 19,514 people in the vaccine group were hospitalized with COVID-19 starting 14 days after vaccination. That compares with 29 hospitalizations among the 19,544 people in the placebo group. None of the vaccinated people died, but there were seven deaths related to COVID-19 in the placebo group. Those numbers are small and some researchers say the data aren’t clear-cut on the benefits.

“The data indicate that the vaccine is effective, but doesn’t prove that the vaccine is especially effective against moderate to severe COVID,” said Diana Zuckerman, president of the National Center for Health Research, a Washington, D.C.–based think tank that analyzes health research.

The data were also collected after only two months of follow-up. Normally, the FDA requires a year or more of data to fully approve a vaccine. Some questions about the vaccine can’t be answered with less than six months of data, Zuckerman said during a public comment period in the Feb. 26 advisory board hearing.  “Let’s be very honest with the public about what we do know and what we won’t know” for some time to come.

For all the vaccines, no one knows how long immunity will last. And what’s already authorized might need to be tweaked if resistant variants become widespread. Booster shots may be needed, Benjamin says.

[….]

To read the entire article, click here.

Who Will Be the Next F.D.A. Chief?

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Sheila Kaplan, New York Times: February 20, 2021

One month into his presidency, President Biden still has not named a candidate to head the Food and Drug Administration, a critical position at a time when new vaccines and coronavirus treatments are under the agency’s review.

The glaring vacancy lags behind the president’s selections of most other top government health posts, and has spurred a public lobbying campaign by supporters of the two apparent front-runners, Dr. Joshua Sharfstein, a former high-ranking F.D.A. official and Dr. Janet Woodcock, the acting commissioner.

It has also exposed rifts among Congressional lawmakers, within the public health and medical communities as well as the health and drug industries that depend on the F.D.A. for approval of their products. In particular, some public health officials have used the open position to debate the leadership qualifications needed to restore the agency’s morale and credibility after a year fighting both a pandemic and a president who often belittled the F.D.A.’s process for approving treatments and vaccines.

Administration officials say that Dr. Sharfstein and Dr. Woodcock have gone through at least partial vetting for the job. They attributed the delay to their focus on solving Covid vaccine shortages and distribution problems. They also noted that Xavier Becerra, the attorney general of California and who Mr. Biden has nominated for secretary of the Health and Human Services Department, faces Republican opposition that could jeopardize his confirmation.

[….]

Dr. Woodcock’s decades of service at the F.D.A. have made her more of a target for critics, and she has drawn particular fire over her agency roles during the opioid crisis.

Dr. Sharfstein, who held the No. 2 slot at the F.D.A. for nearly two years in the Obama administration, has extensive public health interests. At 51, he is a prolific writer, with more than 100 articles, editorials and journal papers published in the past few years on subjects ranging from training physicians to treating opioid addiction to reducing drug prices. He often criticized the Trump administration’s pandemic response, and called for the F.D.A. to “stand up for itself and for science, not politics.”

Early in the coronavirus outbreak, Dr. Sharfstein urged public health officials to focus on protecting racial and ethnic minorities, poor people and others who face social inequities. He has called for expanding housing to hold people with mild symptoms in quarantine; protecting tenants from eviction and offering incentives to food providers to deliver food to low-income neighborhoods for free or at a discount. He also proposed a federal coronavirus insurance program.

[….]

“I think Josh would be a good choice,” said David Nexon, a former executive at the Advanced Medical Technology Association, known as AdvaMed. “He’s a very smart guy, very committed to public health and he has a broad public health background, which would be an asset because of F.D.A.’s wide-ranging responsibilities.”

Dr. Woodcock, 72, also commands deep support, especially within the vast network of cancer-related patient advocacy groups, researchers and the drug companies that help finance them. But Dr. Woodcock, who has spent over 36 years working for the agency, has also generated much stiffer opposition in this round than Dr. Sharfstein.

“In the past, even when the F.D.A. review of the drug was scathing, quite often Janet Woodcock or another high level F.D.A. official would be at the meeting, clearly pushing the advisory committee to recommend approval,” said Diana Zuckerman, president of the National Center for Health Research, a think tank and advocacy group. “But by law, these advisory committees are supposed to make recommendations independent of any F.D.A. pressure.”

But the loudest objections to Dr. Woodcock focus on the F.D.A.’s role in the opioid epidemic during her two stints as chief of its drug division, from 1994 to 2004 and then again from 2007 until she moved to Operation Warp Speed last May. (Between those two postings, she held other roles at the agency.)

In January, a group of nonprofit advocacy groups wrote to Mr. Becerra, the health secretary nominee, and Norris Cochran, the acting health secretary, saying that Dr. Woodcock’s 25-year tenure as F.D.A.’s drug division chief should disqualify her from consideration for commissioner.

“Much of the responsibility for the opioid crisis clearly rests with industry,” the group wrote. “But the fact that opioid manufacturers for decades disseminated false claims about the risks and benefits of opioids points to a dereliction of duty” by Dr. Woodcock’s division.

The letter cited a 2017 presidential commission report on the opioid crisis, which found that it was caused in part by “inadequate oversight by the F.D.A.”

Dr. Woodcock’s role in the approval of new opioid products has also drawn strong opposition from some members of Congress, including Democratic Senators Maggie Hassan of New Hampshire and Edward J. Markey of Massachusetts. Senator Joe Manchin of West Virginia, has also been very critical of the F.D.A.’s handling of opioids under Dr. Woodcock.

“Multiple past F.D.A. commissioners have acknowledged that the F.D.A. made mistakes regarding the opioid crisis, yet the agency still has not fully reckoned with its past missteps,” Senator Hassan said in an email. “The F.D.A.’s decision-making processes for the approval and labeling of opioid drugs going back decades remain of serious concern, and it’s important that the next F.D.A. commissioner is someone who has demonstrated that they have learned from the F.D.A.’s past mistakes — not someone who has been involved in repeating them.”

The nonprofit advocacy groups’ letter prompted a defense of Dr. Woodcock orchestrated in large part by Ellen Sigal, co-founder of Friends of Cancer Research. Ms. Sigal is also chairwoman of the Reagan-Udall Foundation for the F.D.A., an influential organization created by Congress to help advance the agency’s mission and to speed development of new medical treatments.

Friends of Cancer Research receives much of its funding from drug companies. The 2019 top donor list for Friends of Cancer Research includes Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly Co., Genentech, Gilead, Merck, Pfizer and PhRMA, the pharmaceutical industry trade group. The Reagan-Udall Foundation receives funding directly from the F.D.A., but also lists drug industry donors, among them: Biogen, Johnson & Johnson, Teva and the Biotechnology Innovation Organization, known as BIO, which gave Dr. Woodcock an award in 2019 in conjunction with the Science History Institute.

[….]

Dr. Sharfstein’s supporters countered with a letter on Feb. 5, signed by 18 top academic physicians and researchers. “Dr. Sharfstein knows the F.D.A. and will ensure that its decision-making is scientifically beyond reproach, transparent and based on the principles of public health,” they wrote.

[….]

To read the entire article, click here: https://www.nytimes.com/2021/02/20/health/Covid-FDA-Biden.html

FDA blasts Merck’s Keytruda data for new breast cancer indication

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Ed Silverman, Stat News: February 5, 2021

Merck (MRK5 ) may have readily turned its Keytruda cancer drug into a medical and financial juggernaut, but its bid to win regulatory approval for at least one additional use may not come so easily, judging by documents from the Food and Drug Administration. The drug maker wants to sell the medicine to combat high-risk, early-stage triple-negative breast cancer along with chemotherapy before surgery, and then by itself after surgery.

[…]

Given the FDA review, though, the likelihood of a recommendation next week is not high, according to Ira Loss of Washington Analysis, who tracks pharmaceutical regulatory and legislative matters for investors. “The agency believes, and we think the (FDA expert) committee will agree, that further data from the trial are needed to make an informed decision,” he wrote to investors.

Another FDA watcher was even more blunt. “It’s important to have good treatment because this disproportionately occurs among Black women,” said Diana Zuckerman, who heads the National Center for Health Research, a nonprofit think tank. “But they’re saying this may not be needed, may not work and may be harmful – that’s pretty damning. And there are some real safety issues that can have terrible impact on patients… This is one of the most negative reviews I’ve ever seen.”

[….]

Read the full article here