Category Archives: News Stories & Editorials

Califf nomination for FDA chief gets mostly high marks

In the News, News Stories & Editorials
By Joyce Frieden, Medpage Today
September 16, 2015

WASHINGTON — The nomination of Robert Califf, MD, as FDA commissioner is getting good reviews from most health policy and cardiology experts.

“He has a very good understanding of industry and academia, and think that will serve him well,” Caleb Alexander, MD, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness in Baltimore, told MedPage Today in a phone interview. “He built and grew the Duke Clinical Research Institute into a behemoth, so he has deep experience in drug development. On the medical products side, he has a deep and comprehensive understanding … from manufacturers and academia, so I think he’ll be very well suited there.”

[…]

Califf was nominated on Tuesday by President Obama; he is currently serving as FDA’s deputy commissioner for medical products and tobacco. Prior to that appointment, Califf was vice-chancellor for clinical and translational research at Duke University in Durham, N.C., where he also co-chaired the Clinical Trials Transformation Initiative, a public-private partnership co-founded by Duke and the FDA to identify and promote practices that will increase the quality and efficiency of clinical trials.

[…]

One area that might cause controversy with Califf’s nomination is his ties to the pharmaceutical industry. “His very close ties to industry [are] his greatest weakness from a public health point of view,” Diana Zuckerman, PhD, president of the National Center for Health Research, a think tank here that researches the safety of medical products for consumers, said in an email. “That’s why Republicans have supported his nomination and many Democrats have opposed it. Those ties have also been a source of great concern to public health experts across the country.”

“If he is confirmed, he will need to show his independence from industry in order to protect the safety of patients and the integrity of the FDA as a public health agency,” she said. “This will be especially important because the 21st Century Cures Act, which passed the House overwhelmingly and is being revamped in the Senate, has the strong support of pharmaceutical and device companies, as well as academic researchers who depend on industry funding, as Dr. Califf did when he was at Duke.”

Read the full article here.

Michael Milken, from junk bonds to legislative advocate

In the News, News Stories & Editorials
By Sheila Kaplan, Boston Globe via STAT
September 14, 2015
WASHINGTON — Nearly 1,200 lobbyists roamed the halls of Congress this year, trying to shape legislation to speed up the federal approval of new drugs and expand medical research. But the advocate who arguably has had the biggest impact on the process isn’t a registered lobbyist at all. It’s onetime junk bond king Michael Milken.

[…]

He has pushed his agenda with a muted public presence, one that stresses quiet messaging over press releases and networking over campaign contributions. His goal is passage of the 21st Century Cures Act, a bill that would accelerate regulators’ review of new medical treatments and boost funding for the National Institutes of Health by nearly $9 billion over five years.

[…]

Not everyone is pleased with Milken’s behind-the-scenes advocacy. While supporters say the Cures Act, a version of which was passed by the House in July, would make it cheaper and faster to get cutting-edge drugs and medical devices to patients, critics warn that it would create dangerous regulatory shortcuts. They fear that Milken is doing the bidding of the Pharmaceutical Research and Manufacturers of America, the drug industry’s main trade group.

“This is a bill that has many provisions that are exactly what PhRMA wants and what the device companies want,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit think tank in Washington.

Please see full article here.

This bill promises to speed up drug approvals so much that it’s making people uncomfortable

News Stories & Editorials
By Carolyn Johnson, The Washington Post
July 8, 2015

The bill slated to land on the House floor on Thursday seems unassailable on its face – the 21st Century Cures legislation promises to modernize medicine and speed the development of lifesaving treatments.

But a vocal chorus of physicians and pharmaceutical industry watchdogs warn that the bill is full of stealth provisions that could actually put sick people in harm’s way, by speeding the development of treatments that are neither safe nor effective.

It’s not exactly easy to oppose a widely-supported bipartisan bill that is often referred to as just “Cures.” But opponents say the proposed law is full of flaws, starting with its name and its key premise: that bottlenecks in the regulatory process are a big reason we haven’t cured cancer, Alzheimer’s, and a panoply of rare diseases.

To drug companies and patient advocates, expedited access to drugs and devices might seem like a huge boon. But critics are worried that the law will relax America’s standards for evaluating new drugs and devices, which are approved based on careful review of evidence — including rigorously designed clinical trials. The bill offers up a slew of new ways to evaluate drugs: for example, allowing antibiotics to be approved based on what would today be considered preliminary evidence — animal and test tube studies and very small trials in people. New medical devices could be approved based on “case histories” — potentially of just a handful of patients.

“The irony is calling this 21st Century Cures, when they’re talking about standards that were left behind in the 20th century, because they were found to not be good,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit, non-partisan think tank that does not accept money from drug or medical device companies.

Here are a few of the provisions that have sparked debate:

-The bill would allow antibiotics to be approved based on laboratory and animal tests and small, early clinical trials.

-The bill allows companies to seek expedited drug approval based on so-called “surrogate endpoints” — early indicators that a drug is working, such as whether a tumor has stopped growing in cancer.

A study published last month in the journal JAMA Internal Medicine found that efforts to expedite cancer drug approval by using such criteria has resulted in the approval of many cancer drugs that do not extend life, but do have side effects.

-The bill also threatens disclosure requirements that are intended to limit pharmaceutical companies’ influence on physicians. The bill would allow physicians to receive speaking fees and gifts from companies without disclosing them, as long as they were for medical education.

Read full story here.

Hope for children’s rare drug approval process

News Stories & Editorials
By Lisa Gillespie, USA Today (Kaiser Health News)
June 7, 2015

Advocates for children with rare diseases are watching closely a congressional effort to streamline the nation’s drug approval process because the bill includes a provision that would extend a federal program that rewards companies making remedies for these young patients.

The reward program, the advocates say, offers hope to families that often have very few options. Approximately 15 million children are diagnosed with rare diseases, and 35% of deaths in the first year of life are caused by them.

“Treatments aren’t getting to kids, and kids deserve more than the leftovers,” said Nancy Goodman, the founder and executive director of the advocacy group Kids v Cancer. Goodman’s 10-year-old son died from brain cancer. She helped push for the original reward program in the hope that children like her son would have access to a wider range of treatments.

The extension of that program is part of the bipartisan 21st Century Cures bill, which seeks to rewrite the rules for drug development to make innovative treatments available faster. The overall bill has generated support on Capitol Hill, but some critics contend that it has the potential to undermine drug safety and to profit drugmakers.

Children’s advocates say there is a shortage of good therapies for rare and often deadly pediatric diseases that can include a wide variety of conditions including cancer, skull deformities or enzyme deficiencies. Pharmaceutical companies have historically been hesitant to test drugs for children because of concerns about potential negative outcomes, children’s ability to consent to treatment and the perception that the market for these drugs was limited. So doctors have often been left to try adult-tested drugs on sick children but without the studies that show pediatric safety or effectiveness. But drugs used on adults don’t always work on children in the same way because of differences in metabolism and maturation of organs.

The advocates say more research needs to be conducted with children. But that testing is a sensitive process. It can be very costly and it requires extra care because there are more stringent ethical protocols to protect these minors, who can’t often give informed consent. Bad results — either injuries or deaths — can set back research efforts and have financial consequences for the company.

With that in mind, Congress in 2011 set up a program to help promote more pediatric drug research. It gives creators of medicine for rare pediatric diseases a voucher that they can use to have another one of their drugs approved quicker than usual — six months vs. a process that can run a year or often more.

Drugmakers can also sell that voucher, which can be a big windfall for a small drug company trying to recoup research and development costs. There have been four vouchers given out since 2014, and one was sold for $67.5 million and a second for $125 million.

The voucher program, which advocates say holds big potential, expires next year. The cures bill seeks to extend it another three years.

“A lot of companies are reluctant to get into pediatric drug development because it’s very difficult if something goes really wrong,” said Alexander Gaffney of the Regulatory Affairs Professionals Society, an association for people involved in overseeing health care or the quality of health care products.

Drugs that are approved for cancer in adults are commonly not approved in kids. “Children are not simply small adults, they metabolize drugs very differently,” Gaffney said.

Critics say that however well-intentioned the voucher program is, it could have some unintended consequences. For example, a company could get a drug approved by theFood and Drug Administration but never bring it to market, if the maker decides it would not generate enough money. Yet the company would still pocket the priority review voucher.

Because of the speed sought by the program, vouchers could be given out without some of the safeguards that come in more traditional testing. For example, the research might not uncover that the drug could be fatal to a child after a few months or years.

Diana Zuckerman, president of the National Center for Health Research, a non-profit group that seeks to represent children and families on health research policy issues, says the rush in moving drugs through the system can obscure problems. Drugmakers “shouldn’t be able to sell it [or use it] unless it works,” she said.

She noted that in some studies as few as 10 kids are included because the disease is so rare. With such a small population size, the company is not likely looking at big profits.

“When you’re doing a study of rare disease, it’s a small sample size and it’s easy to manipulate the data to make it look better than it is,” said. “You don’t want an incentive to represent the company wrongly in the short term,” to get the voucher for another larger drug.

Julia Jenkins, executive director of the EveryLife Foundation for Rare Diseases, an advocacy group pushing for drug companies to spend more on drug development, wants the pediatric drug voucher program extended. She notes that the program is still too new for officials to evaluate whether it is effective.

One problematic part of the current House version, she said, is that it only extends the program for three years, and drug companies generally need 10 years to scratch up investors and research a new drug. The potential reward of expedited drug review might not be enough to allow a company to make a financial plan for a drug based on the program.

The expanded bill covers more than 60 health issues, including a $10 billion boost in funding for the National Institutes of Health and $550 million in extra money for the FDA over the next five years. Other provisions include creating a database of genomic information from a million U.S. patient volunteers and allowing the FDA to approve drugs without the gold-standard clinical trial, instead using smaller observational studies or clinical experiences.

The bill passed the House Energy and Commerce Committee unanimously in May and is expected to come up for a vote in the full House. Senators are in the early stages of working on a similar bill.

See original article here.

Speeding up drug-approval process could have downside

In the News, News Stories & Editorials
By Ed Silverman

Excerpted from The Wall Street Journal, May 30, 2015.

Would a congressional bill designed to jump-start medical innovation end up lowering standards for approving new uses of existing medicines?

Consumer advocates are raising this concern about the 21st Century Cures legislation, which passed the House Energy and Commerce Committee unanimously last week and, in part, is designed to reform the approval process for drugs. Supporters say the bill is a long overdue move that, among other things, will give the FDA the tools to ensure treatments reach patients faster.

But critics say that a section of the bill devoted to drug development is problematic. Specifically, they point to language that would allow the FDA to approve additional uses for drugs without having to rely on randomized controlled trials. These are considered to be the gold standard for determining whether a medicine offers a benefit, and they help gauge the extent to which there are risky side effects.

The bill, however, pushes aside evidence in favor of something called “clinical experience,” which is defined as a mix of observational studies, patient registries and therapeutic use. None of these, however, are viewed as scientifically rigorous for establishing whether a drug may be effective. Instead, critics say the language in the bill is sufficiently, perhaps deliberately, vague.

“Clinical experience is something that should be considered as additional information, but absolutely never take the place of scientific data,” says Diana Zuckerman, who heads the National Center for Health Research, a nonprofit think tank. “By urging FDA to get away from randomized clinical trials, drug makers may have more power to urge the FDA to consider data that is favorable to their product.”

To read the entire article, including similar concerns expressed by Dr. Steven Goodman from Stanford, see http://www.wsj.com/articles/speeding-up-drug-approval-process-could-have-downside-1432857506

Bill to speed approvals for drugs is cut back

In the News, News Stories & Editorials
By Sabrina Tavernise,  New York Times
April 30, 2015

WASHINGTON — Legislation that would have accelerated the pace of federal drug approvals in a way that critics said threatened to erode patient safety was formally released this week, in a scaled-back version with many of the most controversial provisions left out.

The  draft bill  presented at a  hearing  in the House on Thursday represents a less aggressive streamlining of the drug approval process, critics of the earlier draft said, and seems to have secured strong bipartisan support.

The legislation, called 21st Century Cures, has been in the works for months. Its lead sponsor, Fred Upton, Republican of Michigan, said it would speed the pace of drug cures by removing unnecessary hurdles from the regulatory process.

Critics, including top officials at the  Food and Drug Administration,    had expressed concern that the changes would risk patient safety — for example, by potentially permitting shorter clinical trials and letting drug companies use alternative measures of health as evidence of a drug’s effectiveness and safety.

The bill’s supporters said it was a work in progress that had been assembled in one of the most collaborative, transparent processes Congress has seen in years. The sponsors held eight hearings and more than a dozen round-table meetings in districts across the country to gather comment.

“We have a chance to do something big, and this is our time,” Mr. Upton said.

His co-sponsor, Diana DeGette, Democrat of Colorado, said the lawmakers had made “tremendous progress,” recalling “that hokey video” that she and Mr. Upton made to promote the effort last year.

The draft — at about 200 pages it is half its former size — seemed to allay fears among some experts that it would fundamentally rewire the way drugs are approved. Earlier proposals to give drug companies broad powers to promote their products for uses other than the approved ones and to market brand-name drugs for a longer time without generic competition were not included.

The F.D.A. has defended its record for drug approval speed, saying that in 2014, it approved the most new drugs in almost 20 years, and that it moves faster than its counterparts in other wealthy countries. Experts note that pathways exist for expedited approval, and that the F.D.A. is held to relatively strict timelines under other rules set by Congress. Instead, they say, the bottleneck for new drugs is often a matter of the years of research it takes to find them.

Diana Zuckerman, the president of the National Center for Health Research, said earlier versions of the legislation had “considerable micromanaging of the F.D.A. and enormous power given to industry.”

She added, “Most of that is gone.”

But she cautioned that the bill still held numerous provisions she believed put people at risk, including ones she described as lowering standards for the approval of medical devices and antibiotics. The bill would increase the work the F.D.A. must perform, but not the money it receives, and Dr. Janet Woodcock, an agency official who testified Thursday, said that was a concern.

“We are very stretched in our resources,” she said.

One point that is likely to concern the F.D.A. is a provision that would reduce its authority to regulate some software associated with medical devices.

An earlier version of the bill would have let drugmakers use quicker measures for a drug’s effectiveness during testing — for example, changes in blood sugar level instead of a more final outcome, like development of  diabetes. The new draft instead suggests ways the F.D.A. could use those alternative measures, called biomarkers.

The F.D.A. says it already uses them in a substantial share of drug approvals, and Dr. Woodcock told the lawmakers Thursday that the agency did not need additional authority on this count. Progress has been slow in adopting more biomarkers, she said, because they often did not produce enough evidence to allow scientists to draw firm conclusions.

“You have to know those biomarkers are reliable before you can take a chance on a human life,” she said.

See the original article here.

What do stakeholders think of FDA’s latest effort to get patients timelier access to devices?

News Stories & Editorials, news-you-can-use
By Michael Williamson, Bloomberg BNA

The FDA April 8 released two final guidance documents that will help provide timely patient access to high-quality, safe and effective medical devices for unmet medical needs, Jeffrey Shuren, the director of the agency’s Center for Devices and Radiological Health, said in a blog posting.

Reaction to the two documents is mixed – pitting industry against some patient advocates.

One guidance document describes the FDA’s Expedited Access Program (EAP), which should “speed qualifying devices to patients with life-threatening or irreversibly debilitating conditions” without compromising the agency’s high standards for safety and effectiveness, Shuren’s blog posting said. The other guidance document outlines the agency’s current policy on balancing premarket and postmarket data collection during FDA review of premarket approval (PMA) applications. In addition, the document addresses whether or not the circumstances when postmarket data collection is appropriate for PMAs meet the criteria for the EAP.

Two stakeholders seemed pleased with the EAP document. The Advanced Medical Technology Association (AdvaMed), “commends the agency for its efforts to explore supplementary review pathways to provide more timely patient access to new technologies for life-threatening or irreversibly debilitating diseases or conditions that addresses an unmet medical need,” Janet Trunzo, the association’s senior executive vice president for technology and regulatory affairs, told me in a April 9 e-mail.

In addition, Ben Moscovitch, officer with the medical device project of the Pew Charitable Trusts, a nonproft policy organization, told me April 9 many of the recommendations his group made on the draft version of the EAP document were included in the final document. For example, he told me that the EAP final guidance document reflects a Pew suggestion from 2014 that the FDA should require the initiation of postmarket trials and completion of those studies within a certain timeframe.

Not everyone is pleased with the guidance, however. The EAP final guidance “is part of a larger problem where the FDA is bowing to pressure from Congress to weaken safeguards that are intended to protect patients from unsafe medical products,” Diana Zuckerman, president of the National Center for Health Research, told me in an April 9 e-mail. She is also president of the Cancer Prevention and Treatment Fund.

See the original article here.

Medicare panel voices doubts about genetic cancer tests

News Stories & Editorials, news-you-can-use
By Virgil Dickson, Modern Healthcare

The Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) has expressed little confidence in genetic tests that supposedly predict common cancers. The decision raises doubts about whether the CMS will authorize Medicare coverage for such tests.

“This is such a promising and exciting field, but the excitement is far ahead of the data,” said Diana Zuckerman, a panel member and president of the National Center for Health Research, an advocacy organization. These tests “could be so helpful if only we knew more.”

Specifically, there was a concern among committee members who met Tuesday about the lack of data regarding clinical utility, which indicates if a test result was actually helpful to a consumer.

“The evidence got very thin, very quickly,” said Dr. Beverly Guadagnolo, a panelist and associate professor in the radiation oncology department at the University of Texas.

Industry stakeholders present at the meeting disagreed. “Two hundred-plus labs around the country wouldn’t be doing these tests if they didn’t have clinical utility,” Dr. Jan Nowak, medical director of molecular diagnostics and cytogenetics at NorthShore University HealthSystem, Evanston, Ill., said during public comments.

Another leading concern was to ensure people did not undergo unnecessary chemotherapy. “We need to be on the side of the angels and minimize access to drugs that don’t necessarily need to be given,” said Dr. Josef Fischer, a panelist and professor in the surgery department at Harvard Medical School and Beth Israel Deaconess Medical Center.

The eight-member panel was asked to vote on a scale of 1 to 5 on how confident members were that the tests they were reviewing would actually benefit Medicare beneficiaries by bettering quality of life, helping them avoid inappropriate anti-cancer treatments or death. The tests that were up for consideration claim they help predict the chances of colon, rectum, breast and lung cancers.

Panel member votes were collected and averaged. Most of the tests received an average score under 3, though a test related to breast cancer rated higher at 3.8. Another test meant to find cancerous lung cancer genes scored the lowest at 1.375.

The panelists also were asked to discuss if they would feel more comfortable with a test being used by beneficiaries if it were a laboratory-developed test from a facility certified under the Clinical Laboratory Improvement Amendments or a test that received Food and Drug Administration approval or clearance. Members seemed more comfortable with an FDA-approved test.

It’s unclear what direction the CMS will take moving forward. MEDCAC is generally considered influential, but the agency recently decided to not concur with a committee vote to not recommend Medicare coverage of annual CT scans to detect lung cancer in heavy smokers.

During the meeting, CMS liaison Dr. James Rollins indicated that any future coverage given to these type of tests would need to prove clinical utility. Today, most entities developing these tests focus on proving analytical validity, how accurately a test detects a specific genetic variant, or clinical validity, how well the genetic variant is being analyzed.

See original article here.

Breast implants in France to carry cancer warning: researchers find a ‘clearly established link’

News Stories & Editorials, news-you-can-use
By Dana Dovey, Medical Daily
March 18, 2015

Following France’s National Cancer Institute finding a “clearly established link” between breast implants and a specific type of cancer, the country will now order all breast implants to come with a cancer warning. This announcement came after 18 cases of anaplastic large cell lymphoma were directly linked to women with silicone breast implants since 2011.

Anaplastic large cell lymphoma (ALCL) is a type of non-Hodgkin’s lymphoma that affects the blood. The link between breast implants and this form of cancer is extremely rare, so French officials have urged women who already have the implants not to remove them, the Daily Mail reported. Given the severity of the cancer in the few women who do develop it, French officials felt it necessary to inform women of all the possible risks associated with the surgery.

ALCL is extremely rare, affecting around one to six in every three million women who undergo breast augmentation, Medical News Today reported. However, a study conducted by researchers from Cambridge University in the UK found that nearly all cases of ALCL in breasts occurred in patients who had undergone breast augmentation, suggesting a link between the two. Although it’s not clear why silicone breast implants can sometimes cause cancer, the Cambridge investigation did shed some light on the mystery.

“It’s becoming clear that implant-related ALCL is a distinct clinical entity in itself,” Dr. Suzanne Turner, lead researcher of the Cambridge study, told Medical News Today. “There are still unanswered questions and only by getting to the bottom of this very rare disease will we be able to find alternative ways to treat it.”

Breast implants are a very popular surgery, with Dr. Diana Zukerman, president of the National Center for Health Research, explaining that in 2013 alone 300,000 American women opted for the operation. Of these women, around 80 percent undergo breast enhancement for cosmetic reasons while a further 20 percent have breast implants following breast cancer.

This is far from the first time that breast implants have been implicated in causing a health hazard. In 2011, French firm PIP caused global hysteria when plastic surgeons reported an abnormal amount of the implants rupture, the Daily Mail reported. It was later found that the firm had been manufacturing these breast implants using industrial grade silicone intended for use in mattresses.

The implants were subsequently found faulty and banned from use. Women who had already received the implants were advised to have them removed, although European health officials found no medical or toxicological evidence to back this advice.

See original article here.

Candidate to lead FDA has close ties to big pharma

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By Massimo Calabresi, Time

Duke’s Dr. Robert Califf sees closer collaboration between government and industry

Dr. Robert CaliffLast May, Duke University’s Vice Chancellor for clinical research, Dr. Robert Califf, told an audience of executives that the American system for developing drugs and medical devices was in crisis. Using slides [pdf] developed by Duke’s business school, he said the system was too slow and too expensive, and required disruption and transformation. Towards the end of his talk, he put up a slide that identified a key barrier to change: regulation.

Such views are not uncommon in industry, academic research and on Capitol Hill, but they are noteworthy coming from Califf because he could soon be America’s top regulator overseeing the safety and efficacy of the country’s drugs and medical devices. Califf is already set to become deputy commissioner at the Food and Drug Administration (FDA) next month. Now sources familiar with the process tell TIME he is on President Barack Obama’s short list to run the agency following this month’s announcement that its long-serving commissioner, Margaret Hamburg, will step down in March.

The White House declined to comment on pending personnel decisions, but word that Califf is in contention for the top spot at the FDA comes at a key moment. The agency faces potentially dramatic changes this year as Congress prepares to rewrite many of the rules for how drugs and medical devices are reviewed and tested for safety and efficacy. Califf is widely respected in the public and private sectors, but his candidacy is seen by some as a threat to the independence and authority of the FDA, thanks to his views on the need to accelerate change and his deep financial and intellectual ties to the pharmaceutical and medical device industries.

Califf says his salary is contractually underwritten in part by several large pharmaceutical companies, including Merck, Bristol-Myers Squibb, Eli Lilly and Novartis. He also receives as much as $100,000 a year in consulting fees from some of those companies, and from others, according to his 2014 conflict of interest disclosure [pdf]. In an interview with TIME, Califf estimates that less than half of his annual income comes from research money provided by the pharmaceutical industry, though he says he is not certain because he doesn’t tend to distinguish between industry and government research funding. He says he is divesting his holdings in two privately-held pharmaceutical companies he helped get off the ground.

Califf says such collaboration, not just between industry and academia, but with government, too, is the way of the future. “The greatest progress almost certainly will be made by breaking out of insular knowledge bases and collaborating across the different sectors,” Califf says. He says there is “a tension which cannot be avoided between regulating an industry and creating the conditions where the industry can thrive, and the FDA’s got to do both.” He says it would be “useful to have someone [leading the FDA] who understands how companies operate because you’re interacting with them all the time.”

Diana Zuckerman, President of the National Center for Health Research, which advocates for FDA regulatory authority, says such ties “should be of great concern.” Dr. Califf is “a very accomplished, smart physician who’s been an important name in the field,” Zuckerman says, but his “interdependent relationships” raise questions about his “objectivity and distance.” She cites several studiessuggesting the medical products industry uses such ties to influence the behavior and decision making of doctors and researchers, even when the scientists don’t realize it.

The tension over Califf’s collaboration with industry gets to the heart of the future of the FDA at a pivotal moment. While FDA defenders see the collaboration as a threat to its independence, others see close relationships between government, industry and academia as the model for the future. Califf heads a successful and powerful clinical research program, the Duke Translational Medicine Institute, which brings together industry drug researchers, academic scientists and federal regulators to speed drug development and approval. Califf estimates 50-60% of its $320 million in annual research funding comes from industry.

Capitol Hill is considering codifying parts of that collaborative model for the FDA. The powerful Energy and Commerce Committee in the U.S. House of Representatives recently introduced a draft bill called 21stCentury Cures, which would loosen the drug approval and post-market oversight process. Califf says because the bill is still in draft it is too early to pass an overall judgment on it but he says, “I support a lot of the concepts in the bill.”

In the Senate, the Health, Education, Labor and Pensions (HELP) committee has begun work on its own bill, with committee chairman Lamar Alexander declaring, “It takes too long and costs too much to develop medical products.” In a report paving the way for his legislation, Alexander concluded the FDA has grown too large, has fallen behind scientific innovation and threatens American leadership in biomedical innovation. Reform efforts in the Senate may be aided by the support of liberals like Elizabeth Warren who back looser regulations on the medical device industry.

The FDA uses a model for drug testing and oversight largely developed in the early 1960s, with phased trials before drugs and devices are approved for sale to ensure they are safe and effective, and “post-market” studies afterwards to monitor them. Over time, the agency has come to rely on the medical product industry for more than 60% of its budget for post-market monitoring.Accused of regulatory capture by those who see undue industry influence, the FDA has faced attacks from both sides.

That means the FDA has few defenders and will rely heavily on its next commissioner to stand up for it in public and on Capitol Hill. “This is a very dangerous time for the agency,” says Zuckerman of the National Center for Health Research, “It’s under fire in a way that is unprecedented in the last 20 years.”

Califf’s supporters point out that he is among the ten most cited medical authors in America, and that he has spent his career as a clinician helping patients. Regarding the danger of regulators being “captured” by their interactions with industry, Califf says, “The difference between capture and collaboration towards improving human health is a pretty big difference.”

The White House has set no time frame for its decision on Hamburg’s replacement. It has announced the acting commissioner will be Dr. Stephen Ostroff, a scientist and long-time official at the Health and Human Services department, when she steps down in March.

Link to original article here.