Medical Device Industry and FDA Collude

An Industry Takeover at FDA?

Posted in Regulatory and Compliance by MDDI Staff on December 15, 2015 FiDA highlight

A recent controversy highlights the close relationship between FDA and industry, with some critics calling discussion of key legislation by the regulator and the regulated unethical. 

Jim Dickinson is MD+DI's contributing editor.

If the Obama Administration and its improbable industry supporters have their way, Robert Califf will become, sometime in January, the first FDA commissioner to “capture” the agency from the inside with a full remit of enthusiastic support from its regulated industries.

Califf has been on the FDA payroll as a deputy commissioner since he came from a Duke University cardiology professorship last January—a move seen at the time as setting him up for the commissioner’s slot.

His nomination has been vigorously attacked for the same reason it was quietly aborted in 2009 in favor of Margaret Hamburg—his long career at Duke University consulting with numerous drug companies, far more contact, and much closer, than any prior commissioner.

Califf’s looming appointment would seem a far cry from the impartiality standard imposed on his predecessors, perhaps best expressed in the 1978 words of FDA’s then-chief counsel Nancy Buc—to demonstrate “a healthy tension” between the agency and the industries it regulates by maintaining an “arm’s length” relationship.

That sounds quaint now. It comes from ancient history, being in vogue long before user fees came to FDA in 1993, bringing in their wake radical changes to the previously nervous FDA-industry relationship.

Today fee-empowered companies and their multiple Washington lobbies routinely sit down with FDA and its congressional minders at distances closer than arm’s length.

Among other things, they write legislation together. Behind closed doors.

News about this erupted in December, scandalizing public-interest watchdogs like Pubic Citizen and the National Center for Health Research’s Diana Zuckerman, who told Inside Health Policy the practice would never have been tolerated when she worked on Capitol Hill (1985-95).

“As a senator, President Obama would have spoken out forcefully against this, but this is his administration, so what is he going to do about it?” she asked.

The online publication broke the story after receiving emails and documents from FDA pursuant to Freedom of Information Act requests that showed close collaboration between AdvaMed and FDA in developing the 21^st Century Cures Act, which has passed the House despite criticism from former FDA commissioner David Kessler and others concerned that it could weaken FDA product approval standards.

For its part, Public Citizen publicly condemned senior FDA officials, including Califf, acting FDA commissioner Stephen Ostroff, and CDRH director Jeffrey Shuren, for “colluding” with AdvaMed on the bill, which the activist group said in a December 11 news release “would eviscerate the already far-too-weak safety rules for medical devices.”

Califf, it complained, “participated in at least one high-level strategy meeting with the industry regarding these efforts. No one from the FDA should ever have been involved in such a process, which violates the most elementary ethical standards...

“In response to this outrageous news, the U.S. Senate should, at minimum, halt consideration of Dr. Califf’s nomination until it has an opportunity to investigate fully exactly what occurred. We believe that news of Dr. Califf’s participation in this collusion with industry provides still further evidence that his nomination should be rejected.”

IHP reported that FDA and AdvaMed “had jointly written legislative text for Energy & Commerce chairman Fred Upton’s (MI) signature piece of legislation.”

The distinction between the unseemliness of FDA jointly writing legislative text with industry and conscientiously listening to industry’s viewpoints on the bill’s draft language seemed to be lost on both FDA and AdvaMed after the uproar arose.

An FDA spokesperson told IHP that agency officials “routinely meet with a diverse group of stakeholders” that include industry, as well as patient groups and consumer groups.

“With respect to 21st Century Cures, FDA met with industry, patient groups, consumer groups and other interested stakeholders to better understand their interests and concerns. Congress regularly asks us for technical assistance about how to modify language proposed by outside groups, as was the case here.”

An unnamed AdvaMed official was quoted by IHP as saying there’s nothing unusual about Congress seeking input from stakeholders, including regulatory agencies and trade associations during the legislative process. “The fact that an association and an agency might discuss how a particular piece of legislation might be operationalized or might impact them is not uncommon,” the official said.

Even a spokesman for the Energy & Commerce Committee weighed in to placate concerns that something untoward was going on with the 21^st Century Cures Act. The committee and its members welcome input from all parties, including stakeholders, outside experts and government agencies, and encourages parties “in and out of government” to find consensus around specific policy proposals.

All just business as usual, no big deal, everyone said.

So who’s right? The public-interest complainers who were kept out of the joint FDA-industry legislation-writing meetings, or the insiders who participated and are happy with the process the way it is?

To my mind, the answer depends on whether you trust the government to do the right thing when it huddles with industry behind closed doors in one scenario while it tries to discharge its statutory, user fee-influenced responsibilities with the same industry in another scenario.

The IHP report said that when asked about information that CDRH director Shuren had attended AdvaMed board meetings, FDA refused to release details of Shuren’s calendar and meetings.

This raises another troublesome issue pertaining to trust: FDA’s increasing secretiveness since it acquired, along with all other government bodies, the ability to exclude the public, including or especially the news media, from its inner daily processes and personnel.

This came about after the 9/11 terrorist attacks and physical security was installed in all government buildings. Prior to this, anyone, including journalists, could just walk in and talk to anyone who wanted to talk to them.

A lot of management-unapproved internal information leaked out this way, feeding trade media with early, pre-decisional news about policy developments, personnel moves, incubating regulatory and enforcement initiatives, turf battles, rumors and gossip.

All that has disappeared.

FDA has been zealous in expanding its “security” screens far beyond the merely physical (bag searches, ID checks, metal detectors, etc.) to impose visitor escort rules under which nobody speaks to anybody without pre-clearance and active monitoring, mugshots, and electronic recording—all for your “protection,” of course.

In addition, all news media contacts, whether phone or email, are screened, diverted, or denied by so-called Public Information Officers for suitability and whether or not they will reflect credit on the agency.

IHP got access under the Freedom of Information Act to emails and documents that did not reflect credit on the agency.

Perhaps the screeners failed to see danger in the documents and emails they released.

I have had some of my requests delayed in processing so long they were useless in a news sense when the requested documents finally showed up years later, and even several that never showed up at all.

This, of course, never happens with requests from user fee-paying regulated industry.

Or does it?

http://www.mddionline.com/blog/devicetalk/industry-takeover-fda-12-15-15

Injured Device Patients Blitz CDRH’s Shuren

Injured Device Patients Blitz CDRH’s Shuren

Jim Dickinson

Posted in Regulatory and Compliance by mthibault on October 19, 2015

“Hey, hey FDA, how many people have you killed today?” Not since a chanting, angry crowd of hundreds of AIDS protesters blocked the street outside FDA headquarters in 1988 has the agency seen anything like the eruption of anger that CDRH director Jeffrey Shuren saw in his email inbox in October.

The modern-day equivalent of that mass demonstration 27 years ago (it was eventually effective in getting faster reviews for AIDS drugs) consisted of hundreds of angry patients bombarding Shuren with individualized templated letters demanding that he revoke the PMA for Bayer’s Essure permanent birth control device and resign his office.

The email campaign was organized by power morcellator activist Hooman Noorchashm, a Philadelphia-area cardiothoracic surgeon, and his physician wife Amy Reed, who herself was injured by a power morcellator that spread cancer throughout her body during a hysterectomy.

Thus two separate email campaigns by hundreds of injured patients merged, both focusing on medical devices that treat the female reproductive tract.

This bifurcated effort was quickly joined by a third injured-patient campaign that co-opted Noorchashm’s email template to the extent of demanding Shuren’s resignation and the revocation of PMAs for LASIK-approved lasers.

As the forces were joining, the email campaign folded in a new element: Shuren’s wife, Allison, was discovered to be a partner at the heavily FDA-oriented law firm of Arnold & Porter, and she had medical device companies as clients. Shuren was, therefore, “literally in bed with industry,” Noorchashm alleged in emails to his network.

Publicly targeting an individual FDA official several tiers below the commissioner, who as a political appointee may be expected to bear the brunt of public attacks, is an approach that is precedent-setting. As such, it’s likely to be seen again—all the more so because many of the complaining women indicated in their emails a bitter awareness of the fact that they can’t seek redress in the courts because of FDA preemption.

Since the 2008 U.S. Supreme Court decision in Riegel v. Medtronic, devices like Essure and the LASIK lasers that have PMAs have been preempted from state court product liability claims.

According to the Noorchashm-Reed template letter to Shuren, CDRH’s “inability to properly consider the adverse consequences of nickel allergies and hypersensitivity in some [Essure] patients, as well as the evidence of fraud and data tampering at the time of this device’s approval, renders this PMA status invalid. These failures have very literally harmed thousands of young and otherwise healthy American women since 2002.”

The template left room for women to insert their own post-Essure adverse experiences, just a small sampling of which follows—

Tiki: “I have had uncontrollable bloating and nothing I do relieves it. My sex life with my husband has suffered due to constant cramping. I have had numerical infections in my abdomen no one can figure out what it is or get rid of it. I randomly break out in hives for no reason. This product has ruined my life for 6 long years it's time you listen to the women who are suffering. I now have to go through major surgery to get these terrors out of my body.’

Ambi X: “My story started August 31, 2010 when my decision was made for me to be sterilized by the essure device. From that day on, my life has been changed forever. This ‘non-surgical’ procedure has resulted in a partial hysterectomy, due to the migration of my left coil that was found through exploratory surgery to be lodged near my right kidney, and with residual side effects ranging from Chronic Fatigue, numerous autoimmune diseases and in no way am I able to be the Wife, Mother, Daughter, or Friend that I used to be.”

Tamara: “Just a few weeks after enduring the excruciatingly painful placement of Essure, I knew something was terribly wrong. I lost 10 pounds, had extreme abdominal and pelvic pain, suffered burning sensations throughout my body, blurred vision, slurred speech, muscle weakness, and other adverse effects. No one could explain my symptoms. I endured 3 months of feeling like I was being poisoned to death before I found a doctor to remove the device. In the last 3 years I have undergone 2 surgeries to remove my reproductive organs, over 20 Emergency room visits, countless doctor and specialist appointments, invasive tests, and developed fibromyalgia and allergies. I lost my ability to be gainfully employed and have had to miss time with my family. Essure has destroyed my health and my life as it was.”

Lusine: “In October of 2012, after deciding that my family was complete after having 2 beautiful children, I made the decision to get the Essure Procedure done because it was advertised as safe, non surgical and effective. Little did I know shortly after my health will dramatically start to decline. At the age of 35, I feel like a 70 year old. Getting out of bed to go to work every day has become a daily struggle.  I feel like my children have lost their mother for the last 3 years. I now have chronic pelvic pain, back pain, major hair loss, very painful and heavy menstrual cycles, dental issues, aches all over my body, extreme fatigue and depression. As a single, hardworking mother, all I can do is push forward through all the pain.”

Zenia: Immediately after Essure placement, I was diagnosed with Myasthenia Gravis, Followed by Anemia, Low Thyroid Graves Disease, Multi-function Motor Neuropathy, Fibromyalgia, and migraines. I've experienced hair and tooth loss, become legally disabled, undergone a hysterectomy, experienced severe pain, cramping, weakness, dizziness, memory loss, stuttered/slurred speech, and generalized body weakness.

An FDA spokeswoman told me the agency was aware of the email campaign, and “we are reviewing all of the emails received.” She declined to answer questions about how Shuren was managing his bloated inbox and what response he was making to the angry email senders.

Of course, in a bureaucracy like FDA, that will likely all be taken out of his hands and handled by others for him. Except for the resignation demand, which FDA’s responses (if there are any) will almost certainly ignore.

Flushed with the success of his campaign, Noorchashm sent Shuren an email on October 16 that concluded: “Dr. Shuren, I advise you to resign immediately. There are many harmed Americans who now know what you have allowed to happen from your leadership post at CDRH. Your center is not protecting the public's health, it is protecting industry interests—and that, sir, is treason against the America’s public health.”

It took four or five years for FDA to placate the AIDS protest movement of 1988, and although the 24-7 news cycle, Internet, and social media innovations since then have accelerated the pace of events and government reactions to them, it will likely take at least that long to placate the injured patient movement.

A major element that was not present in 1988 is the funding of FDA by industry in the form of user fees. This means that injured patients have “no skin in the game.”

All they can do is complain and in so doing hope to attract support from Capitol Hill, where industry has long ruled the roost through campaign contributions and PAC support.

Jim Dickinson is MD+DI's contributing editor.

Social Media and Patient Activists: Read this!

510(k) Under Attack

Created 02/18/2015 - 17:36

Posted in Regulatory and Compliance [1] by MDDI Staff on February 18, 2015

Regulatory and Compliance

The most common pathway to market for medical devices is coming under fire from a social media campaign led by activists determined to get FDA to ban power morcellators used in hysterectomy procedures. 

Jim Dickinson

The main portal for admission of new medical devices to the market, Section 510(k) of the Food, Drug, and Cosmetic Act, is under attack again, this time from an unlikely quarter: an unconventional and social media-driven campaign led by Philadelphia cardiothoracic surgeon Hooman Noorchashm and his wife, anesthesiologist Amy Reed.

In February, the Philadelphia Inquirer published an article by Noorchashm in its Sunday health section headlined “A modern-day wolf in sheep’s clothing: FDA’s Center for Devices and Radiological Health (CDRH) [3]”—just the latest salvo in the couple’s 18-month multimedia efforts to ban power morcellation devices used to perform hysterectomy procedures. The article opened a new front in the couple’s fight: to repeal or radically alter Section 510(k).

Their campaign began after Reed’s hysterectomy with a Karl Storz power morcellator spread cancer throughout her abdomen, joining a general one-in-350 incidence rate in power morcellation, according to FDA.

Their efforts have been remarkably successful so far, attracting congressional as well as media support and culminating last November in an uncommonly rapid FDA “immediately in effect guidance [4]” urging manufacturer adoption of a boxed warning and two label contraindications. FDA guidances by definition are nonbinding, however.

Even this small step was swiftly denounced by the American Association of Gynecologic Laparoscopists, which has renamed itself simply AAGL, at its annual meeting in Vancouver, where it declared power morcellation “an effective, lifesaving tool in gynecologic surgery when used appropriately” that “should not be abandoned despite recent concerns about the dissemination of occult cancers.”

FDA’s modest, voluntarism-based action wasn’t enough for Noorchashm and Reed, whose campaign for an outright ban so far has attracted more than 87,000 signatures on a cyber petition [5] to end the devices’ use in all gynecological procedures.

They also want Section 510(k) itself repealed or amended to include a proof-of-safety requirement and a rigorous postmarketing surveillance requirement.

In February, their local Congressman, Republican Mike Fitzpatrick, was preparing a bill to do just that, according to Noorchashm (at press time, Fitzpatrick’s office had not responded to my request for confirmation).

FDA’s implementation of 510(k) has plenty of deficiencies. Five years ago, there was the memorable tumult over the collagen scaffold which, after two years of controversy and corrupt CDRH review allegations, the agency was forced to admit should never have been cleared for marketing [6].

As in the power morcellator case, a key and recurring theme is 510(k)’s gaping loophole on what “substantially equivalent” really means. Both devices were only vaguely similar to their predicates, and predicate-creep over years and even decades without any second look at safety documentation for new-technology products is a disconnect that should be obvious.

Not if there’s market millions to be made in that disconnect, and in user-fee funds (currently $5018 per submission) to be garnered at FDA. This combination understandably brings with it a certain degree of elasticity in “substantial equivalence” determinations by a CDRH that has come to regard product sponsors as “customers.”

When further combined with industry campaign support for candidates of both parties, this fiscal interdependency arguably enabled both Congress and FDA to ignore or dismiss a recommendation in the 2011 Institute of Medicine [7] report on 510(k) that the agency’s 510(k) program be scrapped.

In its place, the report said, should be a new regulatory framework for Class II devices that is not based on “substantial equivalence” but rather on an “integrated premarket and postmarket regulatory framework that effectively provides a reasonable assurance of safety and effectiveness throughout the device life cycle.”

The collagen scaffold and power morcellator controversies haven’t been the only storms to rock FDA’s 510(k) boat, and they likely won’t be the last. The IoM report cited safety issues with an artificial hip, surgical mesh, and medical-tubing connectors, among others.

In Noorchashm’s opinion, and that of former FDA medical device compliance director and noted device attorney Larry R. Pilot—a fierce defender of 510(k) which he helped write—a major issue is the quality of CDRH’s management, processes, and culture.

Noorchashm and other critics fault the center for “being in bed” with industry, while Pilot and others fault it for “incompetence” and failure to use the tools available to it to resolve problems.

These are legitimate issues, but they’re unlikely to be easily eliminated because they are deeply rooted in the very nature of government, across the board, in the American political system. Stakeholders have to be heeded, and the more money they have, the more they have to be heeded.

This is a dynamic that may be about to undergo radical change—something that Noorchashm and others representing injured patients are counting on.

Social media have given them potent tools they never had before. People-power is evolving as a key factor in government decisionmaking. FDA’s timid action on power morcellators came as swiftly as it did largely because of the effectiveness of Noorchashm’s skillful, even adroit multi-media efforts, especially after the Wall Street Journal [8] promoted them. He also credits FDA associate commissioner for policy and planning Peter G. Lurie [9]’s active cooperation.

Social media are changing everything. As mainstream media struggle to adjust, print yields to digital, and Twitter and Facebook replace the evening news, health activists representing injured patients and their families will eventually truncate FDA’s fossilized internal processes, gain seats at the table, and counter the heavy, hidden hand of the influence peddlers.

It’s coming faster than you might think. President Barack Obama’s widely reported initiative on precision medicine [10] actually would enlist “a million or more Americans to volunteer to contribute their health data to improve health outcomes, fuel the development of new treatments, and catalyze a new era of data-based and more precise medical treatment.”

The million or more may be expected to become much more interested, if not activists, in patient care technologies and their governance.

The precision medicine initiative aims to recruit collaborative public and private efforts to “leverage advances in genomics, emerging methods for managing and analyzing large data sets while protecting privacy, and health information technology to accelerate biomedical discoveries.”

Whether or not a Republican-controlled Congress goes along with this initiative—and there are signs that it might—FDA and industry’s old ways of doing things in Washington, DC, and at grassroots are already undergoing seismic change.

A grassroots challenge to 510(k) could be just a beginning. For those with long memories, it was a gynecological device, the Dalkon Shield IUD, and injured patient activism that fueled much of the legal and public agitation that led to the 1976 Medical Device Amendments and the enactment of Section 510(k).

The new patient-powered insurgency could be at least that effective, this time around.

Jim Dickinson is MD+DI's contributing editor.