Category Archives: In the News

Senate Approves FDA’s ‘Breakthrough Pathway’ for Medical Devices

In the News, News Stories & Editorials,
Gail Kalinoski , Contributing Reporter, Health Care Business:  March 23, 2016

A bipartisan Senate committee has approved three bills that could help get medical devices to patients sooner by creating a “breakthrough pathway” through the U.S. Food and Drug Administration, but not everyone is happy about the actions.

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Diana Zuckerman, president of the National Center for Health Research, wrote on behalf of the watchdog group that it was “concerned that the focus of these bills is on getting medical products to market more quickly, instead of making sure they are safe and effective.” The group’s letter added: “Whether creating a new breakthrough pathway for devices (which already are approved based on much lower standards than drugs) or deregulating health IT software, for example, patients will be at risk.”

The group said it strongly opposed one of the bills passed, the Medical Electronic Data Technology Enhancement for Consumers’ Health Act, (S. 1101) known as MEDTECH, stating it would remove “potentially lifesaving and life-threatening health IT software entirely from the FDA’s regulatory oversight, and could possibly eliminate recalls for IT devices with life-threatening flaws.”

But the Advanced Medical Technology Association (AdvaMed) applauded the bills approved earlier this month by the Senate’s Health, Education, Labor & Pensions (HELP) Committee.

[…]

AdvaMed also supported the HELP committee’s work on the Advancing Breakthrough Devices for Patients Act (S. 1077) and the Combination Product Regulatory Fairness Act (S. 1767).

“Taken together, these three bills will help improve patient access to some of the latest medical advancements and foster a more efficient, predictable and transparent review process within the FDA, all the while maintaining the agency’s strong standards for safety and effectiveness,” Scott stated.

Zuckerman’s group disagreed, once again opposing the bills for lowering standards and undermining or micromanaging the FDA. Her letter stated that the vague language on what classified a device as “breakthrough” may “encourage many device companies to apply for ‘breakthrough’ status, overwhelming the resources of the FDA.”

The National Center for Health Research also claimed that smaller clinical trials could compromise the majority of patients because they may have “fewer women, people of color and patients over 65 – often too few to ensure that the device is safe and effective for those groups.”

[…]

Read full article here.

US Device Industry and FDA “Colluded” on Legislation to Weaken Regulatory Oversight

In the News, New Cancer Research
Jeanne Lenzer, THE BMJ: December 17, 2015

US Food and Drug Administration officials had multiple meetings with leaders of the medical device industry to craft legislation that critics say will severely weaken regulatory oversight of the industry, an investigation by the online news service Inside Health Policy has found.

The revelations, discovered in emails and documents obtained under the Freedom of Information Act, have led to renewed calls by professional and public interest watchdog groups to defeat companion legislation to the proposed 21st Century Cures Act, which has been referred to the Senate. They have also called to oppose the approval of Robert Califf as a nominee for the role of FDA commissioner because he took part in meetings with the Advanced Medical Technology Association (AdvaMed), a trade association for medical technology companies.

[…]

Michael Carome, director of the health research group at Public Citizen, a public interest organization, described as “unseemly and inappropriate” the meetings between the FDA and the device industry to craft the language in the act.

Carome said that Califf’s “participation in this collusion with industry” should, at a minimum, put Califf’s nomination as FDA commissioner on hold pending an investigation. Carome said, “The attitudes [Califf] has developed over his decades long history of extensive financial ties to pharmaceutical and medical device companies leave him all too willing to promote the interests of regulated industries over those of public health and patient safety.”

The National Physicians Alliance, together with Public Citizen and six other organizations, wrote a letter to the House of Representatives on 19 May, stating that the 21st Century Cures Act “fails to ensure a . . . scientifically based approach” to drug and device approval and that it will allow “unsafe and ineffective drugs and medical devices to enter the market.”

[…]

The FDA defended its meetings with the industry, telling The BMJ that “FDA officials routinely meet with a diverse group of stakeholders.” The agency said that it had met with 12 representatives of public interest and professional organizations who attended a meeting on 28 October, after the bill was referred to the Senate in July.

Diana Zuckerman, president of the National Center for Health Research, whose organization requested the October meeting, told The BMJ that none of the more than two dozen non-profit organizations that are members of the Patient, Consumer, and Public Health Coalition had been invited by the FDA to help develop any provisions of the 21st Century Cures Act or its Senate companion bill.

She said, “There’s a world of difference between talking about approval standards in general and crafting specific legislative language. It is outrageous that FDA officials and regulated industry are sitting down to craft legislative language to give to congressional staff.”

[…]

BMJ 2015; 351 Cite this as: BMJ 2015;351:h6820

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Senate Committee Approves Legislation to Speed Approval of Medical Devices

In the News, News Stories & Editorials
Thomas M. Burton, The Wall Street Journal: March 9, 2016

WASHINGTON—A Senate committee Wednesday approved a slate of bills that would relax requirements for approval of medical devices by the Food and Drug Administration, part of a larger effort aimed at speeding up the regulatory process and boosting medical research.

Most of the measures were approved with bipartisan support, but there are indications of discord on the package. Some patient-safety advocates said the legislation would weaken the FDA’s ability to ensure the dependability and safety of medical devices.

[…]

At issue is how aggressively the FDA will regulate medical products. The “breakthrough” [products] bill, for example, would allow the use of shorter or smaller clinical studies and quicker measures of success, and medical-device safety experts have already expressed concern that the standards for device approval are significantly lower than those for drugs.

[…]

The “breakthrough” bill “sets a low bar to qualify for ‘breakthrough’ status’ ” and “lowers standards for safety and effectiveness,” said Diana Zuckerman, president of the National Center for Health Research in Washington, a medical research and advocacy group.

[…]

“We are concerned that the focus of these bills is on getting medical products to market more quickly, instead of making sure that they are safe and effective,” Dr. Zuckerman wrote on behalf of her group and 13 other medical safety groups in a letter to the senators on the HELP committee.

To read the full article, click here.

Phrma: Easing Speech Limits Could Reduce Need for Subgroups in Trials

In the News
Joe Williams, Insidehealthpolicy.Com: March 7, 2016

As FDA faces pressure from consumer groups to mandate demographic subgroup participation in trials, the pharmaceutical industry argues a better solution is to let industry communicate real-world information about the safety and effectiveness of marketed products.

Attendees at a recent FDA public meeting on the implementation of a federal action plan to encourage greater use of demographic subgroup data in new drug and device applications urged the agency to mandate inclusion of specific populations in clinical trials as a contingency of approval.

A representative for the pharmaceutical lobby, however, said that such a requirement would prolong clinical trials, and instead said allowing drug companies to share truthful, non-misleading information that does not impact the risk-benefit profile of approved medications would allow industry to communicate data on safety and effectiveness in subgroups in the postapproval space.

[…]

Ulrich said it was necessary to balance getting the perfect answer with the need to provide medicines to those patients who need them.

Drug and device approvals over the past few years show a lack of representation by key subgroups in clinical trials. Tracy Rupp of the National Center for Health Research said that of the 15 premarket approval devices reviewed by advisory committees in 2014, 60 percent did not include at least 30 African Americans, three had less than 10 and some had zero represented. In the same year, Rupp said one-third did not specify whether any individuals 65 years of age or older participated.

“Most devices that would be used by both men and women did not include subgroup analysis to determine if the device was safe and effective for both sexes,” she said.

[…]

Better communication to inform potential clinical trial participants about the possible benefits to their own health, broader sharing of results and improved compensation were other strategies attendees said could encourage more subgroup involvement in studies.

To see original article, click here. 

Remedy for a Sick Industry

In the News, News Stories & Editorials
Peter Korn, Portland Tribune: March 3, 2016

If he were playing it safe, Dr. Vinay Prasad might be among the last to turn into a medical provocateur.

Prasad works at Oregon Health & Science University’s Knight Cancer Institute as a cancer physician, and OHSU has gone all-in trying to make it a flagship department.

[…]

Prasad’s outspokenness and willingness to criticize industrywide assumptions place him in the ranks of a small but influential group of physicians and researchers who are either having an impact on the way medicine is practiced in the United States, or tilting at windmills. That depends on whom you ask.

Prasad’s voice is starting to get noticed on a national stage, says Diana Zuckerman, president of the Washington, D.C.-based National Center for Health Research. When Prasad published a study last year showing new cancer drugs were no more effective than cheaper drugs already on the market, Zuckerman had the work distributed to members of Congress, the White House and science reporters around the country.

“To me, that’s huge news,” Zuckerman says of Prasad’s findings. “Why wasn’t that in every media outlet in the country? Why wasn’t it on every TV news program?”

Zuckerman says she knows why: “It’s not funded by the (pharmaceutical) industry.”

She calls Prasad an iconoclast, and says the work he and others perform detailing conflicts of interest is more important than ever, because there is more money involved today and more lives affected when bad drugs are put into the marketplace.

“It’s one thing when there’s only one cancer drug and it’s not very good, but maybe it’s better than nothing,” Zuckerman says. “But it’s another thing when there are 10 different cancer drugs for the same type of cancer and eight of them have exaggerated their effectiveness in the research, and the two that are perhaps the best are the oldest generic drugs that nobody is advertising or promoting because they don’t cost much.”

[…]

Many of the treatments Prasad assails turn out to have unintended consequences. Ironically, it is just such an impact that has him worried about his own advocacy work, something he calls “the third harm.”

If people lose trust in the medical system, he says, science suffers. He’s aware that fewer than 10 percent of adult cancer patients enroll in clinical trials designed to reveal the best therapies. Still, third harm or not, he says he has to speak out.

Zuckerman agrees.

“It’s hugely important that they’re doing this,” she says. “If they weren’t, nobody would have any idea of what’s going on.”

Read the full article here.

FDA Aims to Speed Clinical Trials, Improve Device Safety Through Post-Market Evaluation, but Funding a Hurdle

In the News, News Stories & Editorials
Joe Williams, Inside Health Policy: February 16, 2016

FDA’s device center chief Jeff Shuren, in an interview with Inside Health Policy, highlighted the benefit a robust National Device Evaluation System could have in bolstering the agency’s ability to monitor devices in real-time to better inform the risk-benefit profile of approved products. Such a system, he said, could also help in the premarket approval phase to reduce the clinical trial burden on manufacturers and get products to market faster.

The program is a high priority for the Center for Devices and Radiological Health within FDA. It was recently listed in CDRH’s 2016-2017 priority agenda, and FDA in the fiscal 2017 budget requested $1.8 million in funding to help establish the system as part of President Barack Obama’s Precision Medicine Initiative. The agency will hold a public workshop in March on the effort.

The goal for FDA, according to Shuren, is to move past the traditional scope of a national surveillance system and launch a program that would allow the agency to more accurately track and analyze the use of medical devices in a real-world setting and better understand the benefits and risks of specific products outside of the clinical trial setting. […]

“I think more money is problem number one and without more money the agency is never going to do a good job,” Diana Zuckerman, president of the National Center for Health Research, told IHP.

Stakeholders have suggested the medical device user fee process is more difficult to navigate than the sister program in the drug center, given the financial disparity in the medical device industry between the large corporations and smaller start-ups. Zuckerman, however, argued that no one is expecting a small device company to pay millions in user fees to cover something like postmarket surveillance.

“There are many small companies and, yes, small companies should have user fees that are affordable, but the medium, large and extra-large sized device companies could be paying a lot more,” she said.

Johnson & Johnson, for example, pays roughly $2.4 million in user fees for a new drug application, sources say, and only $5,000 for a 510(k) submission. A spokesperson for J&J did not respond to inquiries.

Increasing the amount of user fees for the large companies, sources say, could help fund FDA’s postmarket surveillance goals. Sources familiar with the user fee discussions tell IHP, however, that the medical device industry, in particular the Advanced Medical Technology Association, has rejected the notion that industry should have to pay more for faster approvals. […]

 

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Cancer Moonshot Misses the Target

In the News, News Stories & Editorials
Tinker Ready, HealthLeaders Media: February 11, 2016

Hospitals don’t have much to gain from the moonshot, at least in the short run. There are lots of other pressing, fixable problems with cancer care that the Obama administration’s effort won’t address. […]

Let’s assume billions for research are well spent. Everyone is happy when we fund cancer research. Why be a buzz kill? Because, in reality, there are a whole lot of other problems with the way we develop and deliver the treatments we already have.

Prevention and Care Delivery

The Cancer Moonshot might do a lot more to improve the prospects for cancer patients by looking beyond cures and paying attention to problems with cancer care delivery, costs, access and prevention. With hospitals’ fortunes now tied to outcomes and population health, they should be looking for breakthroughs in those areas, not toward another marginally effective $100,000 drug.

Diana Zuckerman is a former Congressional aide and long-time DC-based women’s health advocate. She is one of the founders of the Cancer Prevention and Treatment Fund, a non-profit group that promotes cancer risk reduction and helps patients “in choosing the safest and most effective” treatments.

Zuckerman supports additional research funding. She’s just not sure the moonshot will change much.

“This administration has a year left,” she said “What are they going to accomplish? It takes more than a year. We’ve had so many wars on cancer and we’ve had a lot of progress. But If you want to make meaningful progress, you don’t [just] throw money at a problem for a year.”

Her wish list: Zuckerman would like to see more FDA scrutiny, both before and after approval, of marginally effective cancer drugs. Costs are another issue and one way to keep them down would be to prevent drug makers from charging so much for treatments made possible by publically funded NIH research. Like the moonshot. […]

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F.D.A. faulted for problems with drug tracking

News Stories & Editorials,
By Sabrina Tavernise, New York Times
January 14, 2016

WASHINGTON — Federal investigators said Thursday that there were flaws in the way the Food and Drug Administration tracked drugs after they came to market, raising questions about the agency’s effectiveness as the country’s main drug overseer.

Once the agency approves a drug, it is required to monitor the drug’s safety as well as efforts by the company that makes it to study how the drug is doing in the marketplace, for example whether many patients are reporting problems while taking it. The investigators, from the Government Accountability Office, a nonpartisan investigative arm of Congress, looked at how the F.D.A. was doing with those tasks.

The answer was not very well.

“F.D.A.’s data on post-market safety issues and studies were found to be incomplete, outdated, to contain inaccuracies, and to be stored in a manner that made routine, systematic analysis difficult,” the accountability office concluded in its report.

[…]

“We are shortcutting an important part of the approval process in the hope that we get the information later, but now we’re finding out that’s not happening,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit consumer research group.

[…]

To read the full article, click here.

FDA faulted for failure to track safety issues with drugs already on market

News Stories & Editorials
By Sheila Kaplan, STAT
January 14, 2016

WASHINGTON — Most Americans assume that drugs approved by the Food and Drug Administration are safe to take as directed. But safety concerns often arise only after the drugs go on the market, when companies or doctors tell the FDA about cases of patients who have fallen ill or died from their medications.

On Thursday, however, a federal watchdog agency said the FDA is failing to sufficiently track and publicly disclose instances in such cases.

The Government Accountability Office investigation, conducted at the request of Representative Rosa DeLauro (D-Conn.), raises deep concerns about the FDA’s oversight. It expresses particular concern about the lack of tracking of drugs cleared under two expedited approval programs, which account for about one-quarter of all medicines permitted to go on the market.

“FDA has acknowledged that expediting drug application approvals can pose risks for patients,” GAO investigators wrote, stressing that “postmarket” monitoring for those drugs was especially important.

The investigators also criticized the FDA for failing to post quarterly reports listing certain potential safety issues that it has identified. Despite a statutory requirement that it do so, last year FDA posted no reports at all in its tracking system.

[…]

Diana Zuckerman, president of the National Center for Health Research, agreed the FDA needs to do a better job of monitoring safety issues with drugs that received expedited approval.

“All the pressure now within the FDA, and from patients and Congress is, ‘Let’s get drugs on the market more quickly. Let’s get those cures available to the people who want them more quickly.’ And the FDA has been doing that,” Zuckerman said.

On other hand, she said, the agency also needs to “make sure that better studies are done to see exactly who is likely to benefit and who is likely to be harmed.”

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FDA to create early warning system for medical devices

In the News, News Stories & Editorials
By Robert Lowes, Medscape
December 31, 2015

Hammered for its regulation of medical device safety, the US Food and Drug Administration (FDA) today proposed telling the public about “emerging signals” of possible device risk before it determines whether the risk actually exists.

Such early warnings already are issued for drugs through the FDA Adverse Event Reporting System (FAERS), a database on adverse event and medication error reports submitted to the agency. A dramatic fall-off in the number of drugs flagged for potential risk signals in FAERS since 2012 prompts FDA critics to wonder whether a similar system for medical devices will benefit the public.

In today’s proposal, the FDA explained that it historically has alerted the public about safety concerns that crop up after a device goes on the market, and usually after it has determined what to do about them. Agency responses include recommendations for the “device user community” and possible regulatory action.

However, the FDA said there is a need to notify the public “about emerging signals that the agency is monitoring or analyzing, and for which the agency does not yet have specific recommendations.” […]

Diana Zuckerman, PhD, president of the National Center for Health Research, a think tank focused on children and adults, said she does not believe that the downward trend line means that the FDA has been receiving fewer adverse event reports. Rather, the process of disseminating possible risk signals has become “moribund.”

“We think FAERS information is not being made public in a timely manner,” Dr Zuckerman toldMedscape Medical News. She cites lack of regulatory and political will as the reason. FDA user fees collected from drug manufacturers “are dependent on speed of review for drug approvals, not on timely FAERS information,” she said. “Similarly, Congress has complained about the speed of drug and device approvals, not on the speed of warning safety signals.

“Unfortunately, safety is not currently a priority at the FDA or Congress,” Dr Zuckerman said. […]

To see original article, click here.