Category Archives: In the News

Can the FDA Help Reduce Drug Prices or the Cost of Medical Care?

In the News, New Cancer Research
Diana Zuckerman, PhD, American Journal of Public Health: November 2017

The new US Food and Drug Administration (FDA) commissioner Scott Gottlieb has worked for pharmaceutical companies for most of his career, so it may have surprised some public health advocates when he responded to congressional pressure by taking on the hot issue of drug pricing as one of his first priorities.

In his written for the FDA Web site, Commissioner Gottlieb echoes the view of many public health advocates when he says: “Too many patients are being priced out of the medicines they need. While FDA doesn’t have a direct role in drug pricing, we can take steps to help address this problem by facilitating increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines. […]

I agree with Commissioner Gottlieb that these sound like useful strategies, because generic drugs have been estimated to have saved $1.2 trillion between 2003 and 2012. However, I question how much these strategies can accomplish. Is this a Band-Aid approach to a much more complex problem—and if so, is the FDA part of the problem?

Generic Drugs, Competition, and Drug Prices

The Government Accountability Office (GAO) reported in 2016 that the price of 50-milligram capsules of the antidepressant clomipramine HCL, which is used to treat obsessive-–compulsive disorder, increased by more than 2000% in one year: from 34 cents per capsule in 2013 to $8.43 per capsule in 2014.  The 20-milligram capsules of piroxicam, to treat arthritis, increased by more than 2000% from 2010 to 2015: from 9 cents to $1.82 per capsule. The price of digoxin, a commonly prescribed heart medication, increased by 2800% in a single year.  Despite these increases, the GAO found that from 2010 to 2015 the cost of generics decreased by 59%. Nevertheless, the GAO reported that the price of 315 generic drugs went up by 100% or more during those years, causing financial difficulty for many patients. […]

When a large number of generic manufacturers are making the same product, the average price usually falls to 20% of the branded price, or even lower. There are exceptions, however. For example, eight companies make ursodiol, a treatment for gallstones.  In 2013, the cost was 45 cents per capsule, but in May 2014, Lannett increased its price to $5.10 per capsule, and its competitors soon followed.

Is the FDA Part of the Problem?

The contribution of the FDA to high drug prices was noted recently when the FDA approved an old, commonly used drug for a type of Duchenne muscular dystrophy. Deflazacort had not previously been approved in the United States, but many patients imported generic versions from Europe or Canada for $1000 to $2000 for a year’s supply. When the FDA approved it, a US company gave it a new name, Emflaza, and a new price tag, $89 000 per year (more than a 6000% increase).

Another glaring example of the unpredictable impact of competition involved brand-name drugs for hepatitis C. When Gilead put Sovaldi on the market in late 2013, it cost $1000 per pill: $84 000 for a 12-week course of treatment. The public and policymakers were incensed at what was considered an outrageous cost, but experts assumed the price would soon drop because other similar drugs were in the pipeline. Instead, the official price increased, despite two competing drugs….

FDA Drug Approval

Clearly, when the FDA approves new drugs that create competition, it does not necessarily lower prices. Congress has passed laws to require the FDA to approve drugs and devices more quickly, which Commissioner Gottlieb also supports. This has resulted in lower standards over the last two decades5 and has contributed to the high cost of medical care.

Read the original article here.

Nearly a Dozen Artificial Turf Fields in DC Failed Last Round of Safety Tests

In the News, News Stories & Editorials
Evan Lambert, Fox 5 News: September 18, 2017

A parents’ group known as Tireless DC tells FOX 5 that 11 artificial turf fields in the District have failed their most recent round of testing, leading to closures and replacements, and igniting another debate over the safety of synthetic turf.

D.C.’s Department of General Services (DGS) maintains and tests the 50 synthetic turf fields in the city. DGS did not make a list of the 11 failing fields available to FOX 5, but a task order from DGS shared with us shows the city is spending nearly $1 million to replace four turf fields at Janney, Eaton, Ross and Tubman elementary schools.

Tireless DC tells FOX 5 those schools are among the 11 fields that failed an annual test by DGS, which essentially measures how hard the fields are. A number under 200G is considered safe by some industry experts and that is the guideline DGS uses. […]

Janney Elementary School’s principal sent a letter to parents at the start of the school year letting them know the field failed a safety test and that it would be closed for replacement. The field is nearing completion, according to a DGS spokeswoman.

Parents expressed frustration over not learning of the test results sooner and the timing of the repair during the school year.

“The timing is really what was the biggest frustration because if it was known last spring, there was a lot of downtime during the summer, and at this point, it has impacted the practices,” said Janney Elementary School parent Christine Lucy.

Dr. Diana Zuckerman, president of the National Center for Health Research, expressed concern about the fact that the synthetic turf industry faces little government regulation.

“We really know very little about what is in artificial turf, but when studies have been done, they find a wide range of very toxic materials, including materials that can cause children to have attention deficit problems, can exacerbate asthma or obesity and can even in the long run cause cancer,” Dr. Zuckerman said.

In Montgomery County, seven artificial turf fields used by the school system are tested twice yearly by the manufacturers.

Read the original article here.

Safety Checks at DC Playgrounds Under Question After Boy Injured on Crumb Rubber Floor

In the News, News Stories & Editorials
Q McCray, ABC 7 News: October 27, 2017

There’s no hiding 5-year-old Sam loves playing at Washington D.C. parks, but his mother can’t help but think what if.

“He fell about two and a half feet and broke his leg,” Eliza Graham explained.

Sam fell on one of D.C.’s older poured-in-place (PIP) crumb rubber floor playgrounds.

“No one in the District can speak to whether these playgrounds meet fall safety standards,” the mother of three added.

PIP and crumb rubber were D.C.’s flooring of choice for parks until a moratorium last year for health and safety reasons. One of them being attenuation.

Dr. Diana Zuckerman is President of National Center for Health Research.

“As they get older they get harder,” she said. “It can be extremely dangerous even deadly if a child falls.”

Manufacturers push “Gmax” testing to evaluate if PIP playgrounds are soft enough. Seven On Your Side found out D.C.’s Department of General Services (DGS) has never tested its rubber playground floors.

“Playgrounds do not fall under the Gmax testing for us,” DGS Director Greer Gillis said during a public hearing recently. “That’s one of the things we want to do in regards to playgrounds.” […]

Read the original article here.

Streamlined FDA Reviews Fail to Catch Dangerous Glitches in Health Software, Study Finds

In the News, News Stories & Editorials
Casey Ross, STAT News: September 12, 2017

The Food and Drug Administration carefully polices many categories of drugs and devices. But when it comes to software, the agency’s oversight is scanty at best — something that a new study finds is resulting in failure to detect dangerous glitches in software-enabled medical equipment.

The study comes amid ongoing debate over the FDA’s role in reviewing the booming number of software-enabled products in health care.

The study, published in Milbank Quarterly, found that 11 of the 12 software devices subjected to the highest-risk recalls between 2011 and 2015 went through a streamlined review process, known as 501(k), that didn’t require testing for safety and efficacy. The other one was completely exempted from review.

Those recalls included life-sustaining equipment such as ventilators and infusion pumps, as well as a clinical decision support software used to flag adverse drug events during surgery.

“The FDA is allowing many of these products on the market with relatively loose criteria of what is acceptable, and those are the ones that are most likely to end up causing harm,” said Diana Zuckerman, a co-author of the study and president of the National Center for Health Research.

In a response to STAT questions, a spokeswoman for the FDA acknowledged that its review process needs to be updated to reflect issues posed by software-enabled devices.

“FDA’s traditional approach to medical devices is not well-suited to these products,” the spokeswoman, Stephanie Caccomo, wrote in an emailed statement. “A new pragmatic approach must recognize the unique characteristics of digital health technology and the marketplace for these tools, so we can continue to promote innovation of high-quality, safe, and effective digital health devices.” […]

Errors and Glitches

The study examined 627 software devices recalled over the five-year period between 2011 and 2015. Most of the recalled devices (592) were classified as presenting moderate risk; 23 were classified as low risk; and 12 were deemed high risk.

The high-risk recalls involved equipment used in several different settings. Six of the devices were used in anesthesiology, including five ventilators and one decision support tool. The study reported that the software glitches in the ventilators could cause them to stop working prematurely. The decision support tool, used to flag adverse drug events in surgery, could lead to the use of the wrong patient’s data during a procedure. […]

The Impact of Cures Act

The debate over the FDA’s scrutiny of medical software and digital health products is also being played out through implementation of the 21st Century Cures Act, which includes a provision that exempts certain software devices from the agency’s jurisdiction. Zuckerman said the exemption is a step in the wrong direction at the worst possible time, when rapid innovation is producing increasingly complex devices that require deeper scrutiny.

“Our Congress should not have passed a law lowering standards in a way that could be so harmful to patients,” she said. […]

Read the original article here.

Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health

In the News, New Cancer Research
Jay G. Ronquillo and Diana M. Zuckerman, Milbank Quarterly: September 12, 2017

Policy Points:

  • Medical software has become an increasingly critical component of health care, yet the regulation of these devices is inconsistent and controversial.
  • No studies of medical devices and software assess the impact on patient safety of the FDA’s current regulatory safeguards and new legislative changes to those standards.
  • Our analysis indicates that current regulations are necessary but not sufficient for ensuring patient safety
  • New laws will reduce safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients.

Context: Medical software has become an increasingly critical component of health care, yet the regulatory landscape for digital health is inconsistent and controversial. To understand which policies might best protect patients, we examined the impact of the US Food and Drug Administration’s (FDA’s) regulatory safeguards on software-related technologies in recent years and the implications for newly passed legislative changes in regulatory policy.

Methods: Using FDA databases, we identified all medical devices that were recalled from 2011 through 2015 primarily because of software defects. We counted all software-related recalls for each FDA risk category and evaluated each high-risk and moderate-risk recall of electronic medical records to determine the manufacturer, device classification, submission type, number of units, and product details.

Findings: A total of 627 software devices (1.4 million units) were subject to recalls, with 12 of these devices (190,596 units) subject to the highest-risk recalls. Eleven of the devices recalled as high risk had entered the market through the FDA review process that does not require evidence of safety or effectiveness, and one device was completely exempt from regulatory review. The largest high-risk recall categories were anesthesiology and general hospital, with one each in cardiovascular and neurology. Five electronic medical record systems (9,347 units) were recalled for software defects classified as posing a moderate risk to patient safety.

Conclusions: Software problems in medical devices are not rare and have the potential to negatively influence medical care. Premarket regulation has not captured all the software issues that could harm patients, evidenced by the potentially large number of patients exposed to software products later subject to high-risk and moderate-risk recalls. Provisions of the 21st Century Cures Act that became law in late 2016 will reduce safeguards further. Absent stronger regulations and implementation to create robust risk assessment and adverse event reporting, physicians and their patients are likely to be at risk from medical errors caused by software-related problems in medical devices.

Read at: https://www.milbank.org/quarterly/articles/software-related-recalls-health-information-technology-medical-devices-implications-fda-regulation-digital-health/

Statement of Dr. Diana Zuckerman in Honor of Dr. Vivian Pinn

In the News, Press Releases
September 8, 2017

I am going to Charlottesville on September 13 to honor Dr. Vivian Pinn, our 2013 Foremother Awards honoree, as a major research facility at UVA’s School of Medicine is named in her honor.  Dr. Pinn received her medical degree from the University of Virginia in 1967, where she was the only woman and only African American in her graduating class. In 2005, she returned to UVA as the University’s first African-American woman commencement speaker, and UVA’s School of Medicine named one of its 4 student advisory colleges as the “Pinn College” in her honor. UVA’s School of Medicine honored her by establishing the “Vivian W. Pinn Distinguished Lecture Series in Health Disparities.”  And now she is the first African American to have a building named in her honor at UVA’s School of Medicine.

We honored Dr. Pinn with our Foremother Award in 2013.  As the first director of the National Institute of Health’s Office of Research on Women’s Health, Dr. Pinn has had many accomplishments.  But one of her most important was her support for the Women’s Health Initiative, which was the first study to determine that women’s  hormones do not need to be “replaced” after menopause, because combined hormone therapy actually increased the risk of heart attack, stroke, and breast cancer in postmenopausal women.  This study resulted in a drop in breast cancer among women for the first time, and has saved thousands of lives.


L to R: Former NIH Director Dr. Bernadine Healy, actor Pierce Brosnan, and
Dr. Vivian Pinn at a Congressional Briefing on Women’s Health Research in 1992.

Will Controversial Bill Cure or Kill Patients?

In the News, News Stories & Editorials
Celia Wexler, Who What Why: September 7, 2017

In 2016, 10-year-old Joshua Hardy lost his long battle with cancer, in part because of a viral infection that resulted from a bone marrow transplant. Hardy’s family tried to get access to a new experimental antiviral drug from Chimerix, the company developing it. The company refused, not wanting to divert time and resources from its efforts to gain FDA approval for the drug. It agreed to make the drug available only after a social media campaign.

Hardy responded well to the drug, but it was too late.

Hardy’s story is one of those featured in the lobbying campaign for a federal Right to Try (RTT) bill, which passed the Senate in August and may soon get a vote in the House.

But the Senate-passed bill would not require drug companies to provide dying patients access to their experimental drugs. Instead, it largely goes after the Food and Drug Administration, and would remove FDA oversight from the process, while insulating the pharmaceutical industry and doctors from virtually any liability if patients are harmed.

RTT pits some desperate patients, along with libertarians and conservative and anti-regulation Republicans, including President Donald Trump and Vice President Mike Pence, against public health advocates, medical ethicists, and some national patient-advocacy groups.

The bill’s supporters frame the legislation as striking a blow for the rights of patients to try any drug without government interference. They predict that more pharmaceutical companies would give patients access to their unproven drugs if they weren’t worried about the FDA looking over their shoulders.

The bill’s opponents contend that any possible expansion of access comes at the cost of eliminating crucial protections for the most vulnerable patients, potentially hastening their deaths and making their end more painful.

Opponents are circulating a letter to the House this week charging that RTT should actually be called the “False Hope” bill. Indeed, given the philosophical bent of its strongest supporters, and their connection to free-market crusaders Charles and David Koch, RTT may be more about advancing a conservative, anti-government ideology than helping the terminally ill. […]

Diana Zuckerman, president of the National Center for Health Research, points out that drug companies rely on a three-phase clinical trial process to gain FDA approval for their products. If RTT siphoned off patients with life-threatening illnesses from clinical trials, particularly for trials of medications serving limited populations with rare diseases, drug companies might find it even harder to enroll enough patients to complete them. And health insurers will not pay for drugs that lack FDA approval. […]

RTT’s true beneficiaries may be new drug startups that are neither “patient-oriented nor compassionate, trying to create buzz for their product,” Zuckerman said. A biotech startup, she speculated, might be struggling with the high costs of making its product, and be happy to find wealthy, desperate patients willing to pay the freight. This might be particularly attractive since RTT gives patients only limited rights to sue, even if they are seriously harmed by defective products.

Unscrupulous doctors also might benefit, she added, since the law does not place any restrictions on the fees they may charge patients to administer the drug and monitor their progress. […]

Read the original article here.

Cigarette Maker Stocks Plunge on FDA Announcement, But Health Experts Are Skeptical

News Stories & Editorials
Emma Court, Marketwatch: July 28, 2017

A Food and Drug Administration announcement Friday that included a proposal to lower nicotine levels in cigarettes to non-addictive levels sent cigarette maker shares plunging. […]

Health experts said that the Friday announcement focused on important public health priorities, including examining the effect flavors, such as menthol, have in attracting young people to tobacco products and approaching any changes so as to avoid a spike in black market activity.

But they also expressed skepticism about the real-world effects of Friday’s news, and concern about its pushback of reviews for products like cigars and hookah tobacco until 2021 and things like e-cigarettes until 2022. The aforementioned products are already on the market but have come more recently under FDA regulation. […]

And the announcement’s intent matters less than “not just what they ask for, but what they require,” said Diana Zuckerman, president of the National Center for Health Research.

Extending the product review timeline keeps harmful products on the market longer, Dobbins said.

For its part, the FDA said that extending the review deadlines will give the regulator more time along with giving companies “additional time to develop higher quality, more complete applications informed by additional guidance from the agency.” […]

Though the Friday announcement appeared to be a negative for cigarette makers, it could be “an opportunity over the long term for reduced-risk products,” said Wells Fargo Securities analyst Bonnie Herzog, such as Altria and Philip Morris’ smokeless iQOS devices. “We see this as an opportune entry point for long-term investors and would recommend building positions on today’s broad weakness.” […]

Read the original article here.

FDA Deal Would Relax Rules on Reporting Medical Device Problems

News Stories & Editorials
Sheila Kaplan, The New York Times: July 11, 2017

WASHINGTON — Makers of cardiac defibrillators, insulin pumps, breast implants and other medical devices might be able to delay reporting dangerous malfunctions to the Food and Drug Administration under an agreement heading for a vote in Congress.

Device makers will still have to quickly report any injuries or deaths related to their products. They would have more time, though, to file reports on devices that may not be working properly, and have the potential for injury.

The deal is part of a pact between the F.D.A. and the $148 billion device industry. Renegotiated every five years, the agreement includes the fees that device makers must pay for the agency to review their products. It is scheduled for a vote in the House of Representatives on Wednesday. […]

But consumer advocates point to recent problems where initial reports of device malfunctions did not involve any injuries, but later evidence — sometimes additional devices showing flaws or reports indicating patients were harmed — began to surface. They pointed to cardiac defibrillators that ran out of batteries; the power morcellator, designed for laparoscopic surgery to remove uterine fibroids, which spread cancer through patients’ bodies; a type of breast implant that is linked to a rare cancer; and the superbug-bearing duodenoscope, whose design flaws made it virtually impossible to disinfect. […]

Textured breast implants have been linked to a rare form of cancer.Critics of relaxing the rules say this is not the right time to ease oversight when so much already goes undetected.

“It often takes months or even years for the F.D.A. to detect patterns of failure,” said Jack Mitchell, director of health policy for the National Center for Health Research in Washington. “Post-market surveillance of medical devices continues to be dangerously slow and clearly inadequate to protect patients from risky devices.” […]

 Read the original article here.

FDA Eases Notice Requirement on More Than 1,000 Medical Devices

News Stories & Editorials
Mike Stankiewicz, Bloomberg BNA: July 10, 2017

More than one thousand medical devices, including umbilical clamps, menstrual cups, and dentures, will be exempt from an FDA clearance process.The Food and Drug Administration removed 510(k) notification requirements for some moderate-risk devices under steps established by the 21st Century Cures Act ( Pub. L. No. 114-255), a 2016 law intended to speed new drugs and devices to the market and reduce regulatory burdens. The newly exempt devices include commonly used items like dentures, menstrual cups and scented menstrual pads, umbilical clamps, and certain hearing aids. […]

The 21st Century Cures Act requires the FDA to determine which class II devices no longer require the premarket clearance.The FDA said the exemption will help industry by eliminating costs and time required to comply with regulations. […]

Industry, Consumer Reactions

The Advanced Medical Technology Association, a medical device industry group, praised the FDA’s move.

“This action supports a risk-based review process for identifying lower-risk, well-established products for exemption and allows FDA to better focus its review resources to support the public health,” Janet Trunzo, senior executive vice president of technology and regulatory affairs at AdvaMed, told Bloomberg BNA July 10.

But Diana Zuckerman, president of the National Center for Health Research, a Washington-based nonprofit, said the FDA is going in the wrong direction because patients could be hurt by the moderate-risk devices.

“In addition to risks to patients, these FDA actions mean even less information about the devices that will be available to doctors and their patients,” she told Bloomberg BNA July 10. “How can doctors and patients make informed medical decisions without any any public information about these products? And how can medical care in the U.S. be made more affordable without requiring scientific evidence about safety or effectiveness for treatments that physicians are choosing for their patients?” […]

Read the original article here.