DRUG MONEY

In FDA Meetings, "Voice" of the Patient Often Funded by Drug Companies

December 1, 2016
| David S. Hilzenrath
FDA Drug Money Companies

This is part 2 in a series; read the first part, “DRUG MONEY: FDA Depends on Industry Funding; Money Comes with ‘Strings Attached’”

At an August 15, 2016, public forum convened by the Food and Drug Administration, panelist Marc Boutin introduced himself as CEO of National Health Council and said his organization provides “a united voice for people with chronic disease and disabilities.” Speaking at the agency’s invitation, he proceeded to praise a far-reaching deal the FDA had struck with the pharmaceutical lobby—a bargain designed in part to speed FDA approval of new drugs.

Boutin’s comments added credibility to the deal and wrapped it in the embrace of suffering patients, a group bound to evoke sympathy.

But there were a few things neither Boutin nor his hosts at the FDA mentioned.

National Health Council gets most of its funding from drug companies, its members include many drug companies, and representatives of drug companies and their main lobbying organizations serve on its board.

Drug Money Patient Voices Pie Chart

Boutin’s appearance epitomized a larger phenomenon.

Under federal law, the FDA was required to consult patient and consumer representatives before taking a momentous step this year: agreeing to a new, binding plan that will shape the way the agency reviews prescription drugs for years to come.

The law gave the pharmaceutical industry a much more powerful role than it gave patients or consumers. Astonishingly, it required the FDA to negotiate the plan with industry.

In theory, requiring the FDA to hold a series of meetings with patient and consumer representatives provided at least a modest check on the extraordinary influence the negotiations give drug lobbyists over drug regulators.

However, even the token input the FDA sought from patient and consumer representatives late last year and early this year came, in many cases, from groups with ties to the drug industry, the Project On Government Oversight found.

Like National Health Council, the vast majority of the groups the FDA included in the discussions—at least 39 out of 42, or 93 percent—have received funding from drug companies, POGO found.

More than a third of the groups—15 that POGO has documented—have executives, directors, or other personnel from pharmaceutical or biotech companies on their governing boards.

The boards and staffs of groups admitted to the discussions also included others with industry backgrounds such as public relations consultants and lobbyists for pharmaceutical companies, people in other FDA-regulated medical businesses, former employees of drug companies, and people from firms that manage clinical trials for drug companies.

As a result, instead of assuring patients an independent voice at the FDA, the meetings with so-called patient and consumer advocacy groups might have given the pharmaceutical lobby additional avenues for promoting its agenda.

The plan that emerged from the negotiations, which is subject to further revision, includes key items from industry’s wish list. It calls for the FDA to give increased consideration to unconventional types of information when assessing drugs—information such as “patient-reported outcomes” and “real world evidence.” The drug lobby has argued that those could be valuable alternatives to data gathered in scientifically controlled clinical trials, which are costly and time-consuming.

Critics worry that the new approaches could weaken consumer protections and ease the approval of drugs that are dangerous or ineffective. If those fears are realized, the approval of undeserving drugs could not only harm people but also spur wasteful spending by consumers, private health plans, and government programs.

National Health Council and many of the industry-backed groups that participated in the FDA meetings on user fees have also been urging Congress to pass the “21st Century Cures Act,” which is now front and center on Capitol Hill.  The legislation addresses some of the same objectives as the plan the FDA and the drug industry negotiated.

Negotiating with Industry, Consulting with Patients

The FDA’s deal with industry is part of a larger process prescribed by the Prescription Drug User Fee Act, known as PDUFA. Under PDUFA, drug companies pay the FDA fees to review and consider approving their products. The “user fees” account for a major share of the FDA’s budget. However, every five years the fee legislation expires and the FDA is required to negotiate with industry over the terms of its renewal. (See accompanying article, “FDA Depends on Industry Funding,” for more on this.)

The “PDUFA VI” negotiations—so named because they involve the sixth five-year cycle—were conducted over several months in late 2015 and early 2016. The FDA held 70 negotiating sessions with drug industry lobbyists and executives. Over roughly the same time frame, it hosted six “stakeholder discussions” with other groups.

The stakeholder discussions, held between September 2015 and February 2016, were the FDA’s effort to comply with this legal requirement:

PERIODIC CONSULTATION. — Not less frequently than once every month during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes . . . .”

(The reference to the Secretary of Health and Human Services, whose jurisdiction includes the FDA, appears to be a formality.)

The FDA released only vague summaries of the stakeholder discussions, which were closed to the public.

Well after the negotiations with industry and the consultations with stakeholders had ended, the FDA held the August 15 public forum to lay out the results of the negotiations. The agency invited some of the patient advocates—some of the same groups that participated in the stakeholder discussions and had ties to industry—to serve as panelists at the event. In their comments, they championed and helped to validate the five-year bargain the FDA struck with the drug lobby over how the FDA should do its job.

Surrogates

None of the panelists at that FDA event spoke with greater passion or eloquence than Marc Boutin.

“Good morning. I'm Marc Boutin, the CEO of the National Health Council, an umbrella organization of patient advocacy organizations, which provide a united voice for people with chronic disease and disabilities,” Boutin began.

For a long time, Boutin said, “we let others speak on our behalf—our doctors, academics, researchers."

That was inadequate, Boutin said. Years ago, “we decided enough was enough. Surrogates, while critically important, cannot and should not speak on our behalf. We went to Congress and we said, ‘We want to have a role in the agreements.’”

Hence the stakeholder meetings, Boutin said.

Boutin said the latest agreement the FDA reached with industry—known as the commitment letter—“will lead to higher value products” and “will have huge impacts on ensuring that people get the right treatment at the right time.”

“I want to add my thanks to the FDA and industry. You didn't look away, you heard us, you paid attention. We want to work with you to implement” the agreement, Boutin said.

But for whom was Boutin speaking?

His organization, National Health Council, lists as board members the heads of Pharmaceutical Research and Manufacturers of America (PhRMA), the main pharmaceutical industry lobbying group, and Biotechnology Innovation Organization—also known as BIO—the main trade group for biotech firms, plus executives from drug-makers Sanofi, Johnson & Johnson, and Alkermes.

Pie chart showing 2015 funding for the National Health Council

National Health Council’s “Sponsors” page lists many drug companies and industry groups. Those listed as donating more than $100,000 include PhRMA and drug-makers GlaxoSmithKline, Merck, Novartis, Eli Lilly, and Pfizer. In 2014, PhRMA gave National Health Council $1.2 million, according to the most recent PhRMA annual tax filing available through the GuideStar information service. That was the largest of hundreds of items listed in the PhRMA filing under “Grants and Other Assistance to Organizations, Governments and Individuals in the United States,” far ahead of its second-largest contribution, $621,500 to the Michigan Republican Party Administrative Account.

National Health Council’s “Policy Action Team” includes a representative from Johnson & Johnson and one from PhRMA. The PhRMA representative’s LinkedIn profile says she leads PhRMA’s “national alliance advocacy engagement efforts.”

National Health Council told POGO that 77 percent of its funding last year came from the biotech and pharmaceutical industries, including companies and their trade associations.

So is National Health Council a voice for patients—or an advocate for industry?

In a filing with the Internal Revenue Service, the organization says its mission is “TO PROVIDE A UNITED VOICE FOR PEOPLE WITH CHRONIC DISEASES AND DISABILITIES.”  The filing says National Health Council is a tax-exempt 501(c)(3) corporation, otherwise known as a charitable organization.

The website of Pfizer, a big drug company, shows how Pfizer has categorized it.

Pfizer discloses its membership in National Health Council on a page headed “Lobbying & Political Contributions,” listing National Health Council under “Trade Association Memberships,” along with groups such as PhRMA, BIO, U.S. Chamber of Commerce, and Business Roundtable.

The page offers this overview of Pfizer’s trade association memberships:

“Pfizer is a member of several industry and trade groups that represent both the pharmaceutical industry and the business community at large in an effort to bring about consensus on broad policy issues that can impact Pfizer's business objectives and ability to serve patients.”

National Health Council’s “Membership Directory” includes more than 20 pharmaceutical and biotech companies, plus PhRMA and BIO.

As an umbrella group for other organizations, National Health Council also lists as members patient advocacy groups which themselves have ties to industry and which participated in the FDA stakeholder meetings in their own right.

For example, the Leukemia and Lymphoma Society lists drug and biotech companies as “partners and sponsors.” Those named in its “Leadership Circle”—“$1 million and above”—include Bristol-Myers Squibb, Celgene, Genentech, Gilead, Novartis, Pharmacyclics/Janssen, and Takeda Oncology.

The Leukemia and Lymphoma Society discloses that its board includes Joseph B. Kelley—“vice president, government affairs for Eli Lilly and Company.”

“He has been an active member of LLS's National Capital chapter, where he served on the Executive Committee, and co-chairs the chapter's highly successful Annual Leukemia Ball. Kelley has been responsible for raising significant funds for this very successful event,” the Leukemia and Lymphoma Society website says.

The society’s website says another board member, Renzo Canetta, “has more than 35 years of clinical and regulatory cancer research experience at Bristol-Myers Squibb.”

A third board member, A. Dana Callow, is described as presiding director of PAREXEL International Corp., a firm that manages clinical trials for drug companies.

In a statement on its website, the Leukemia and Lymphoma Society says it “applies for industry funding” and “will only accept industry funding that is free of influence as to the content, format or delivery of its educational, research, public policy and fundraising programs.” In its annual report, the society says it “advocates for blood cancer patients and their families.”

The society “is dedicated to removing barriers to care by representing the healthcare and medical research interests of patients and families to policy makers at all levels of government,” the annual report says.

Science or Salesmanship?

Pill capsules

Drug companies’ relationships with patient advocacy groups are part of a larger web of industry connections that includes the consulting fees, honoraria, and travel expenses that drug companies pay to doctors, the ads they buy in medical journals, the research funding they deliver to hospitals and universities, the money they spend on lobbying and political campaign contributions, and the payments they make to the professionals who conduct and write up the results of clinical trials on which the FDA relies when deciding whether to approve drugs.

They show the wide reach of drug company money in the worlds of health policy and medical research.

They are a reminder that what passes for grassroots sentiment in Washington policy debates is not always what it seems.

Such relationships are particularly ironic and cautionary because one of the main commitments the FDA made to industry during the latest round of negotiations is to give the voices and experiences of patients greater consideration when it is reviewing drugs. (See accompanying article, “FDA Depends on Industry Funding,” for more on this.)

“We had some priorities in mind at BIO when we entered this PDUFA [negotiating] cycle over a year ago,” Kay Holcombe of the biotech industry group said at the August 15 forum. “First, the voice of the patient must be heard, listened to, and incorporated throughout drug development and product review and into FDA's regulatory decisions.”

The FDA’s statement of commitments includes such buzz phrases as “Enhancing the Incorporation of the Patient’s Voice in Drug Development and Decision-Making” and “engagement of patients in FDA’s regulatory decision-making.”

Could that create a new opening for the pharmaceutical industry to shape perceptions of drugs or stack the deck in its favor?

When an FDA advisory committee held a public meeting in 2015 to assess a drug for women known as “pink Viagra,” at least six members of the public who got up to speak were paid to be there by the drug’s manufacturer, Vox reported.

Some of the other speakers at the advisory committee meeting, such as Leonore Tiefer, a psychologist who treats women with sexual problems, accused the company behind the drug of using, as she put it, “deception to mobilize women with real sexual concerns to lobby for their questionable product.” Liz Canner, maker of a documentary film on the race to develop a Viagra for females, testified that a campaign called “Even the Score,” funded in part by the drug company, showed “a devious way to use non-profits as a cover for a marketing and lobbying campaign.” It amounted, she said, to “astroturfing.”

The drug company, Sprout Pharmaceuticals, has since been bought by Valeant Pharmaceuticals. In response to an inquiry from POGO, Valeant did not directly address those allegations. In a statement, Valeant said that, when it engages “key opinion leaders” to speak on behalf of its products, they “are compensated accordingly for their services and in alignment with industry standards.”

What passes for grassroots sentiment in Washington policy debates is not always what it seems.

FDA reviewers concluded that the drug’s “marginal clinical benefits” did not outweigh its “serious risks.” The FDA approved it nonetheless. In a memo explaining that decision, Hylton V. Joffe, an FDA division director, said the drug showed “small treatment effects.” However, he noted that there were no FDA-approved medicines for the problem at issue, and he said that, based on the FDA’s analysis, about 10 percent of patients on the drug would have a “meaningful improvement” compared with those taking a placebo.

When another FDA advisory committee held a public meeting in the spring of 2015 to assess a different drug—one for Duchenne muscular dystrophy—the manufacturer arranged for a presentation of “Patient and Caregiver Reported Outcomes,” and the committee heard testimony from patients. While the testimonials were deeply moving and portrayed the drug as improving patients’ condition, scientific data “showed progressive worsening,” an FDA official later wrote. The FDA approved the drug. (See accompanying article, “FDA Depends on Industry Funding.”)

Last year, National Health Council hosted what it called “an invitation-only Dialogue Event at the offices of the Food and Drug Administration” and published a report based on that meeting titled Advancing Meaningful Patient Engagement in Research, Development, and Review of Drugs. Underscoring industry’s interest in the possibilities, the group posted this acknowledgment:

“The National Health Council and Genetic Alliance greatly appreciate the educational grants from the following supporters that made this project possible: Biotechnology Industry Organization, Merck & Co., Novartis, Pfizer Inc., Pharmaceutical Research and Manufacturers of America, and Sanofi U.S.”

PhRMA spokesman Andrew Powaleny said his group “engages with stakeholders across the health care system to hear their perspectives and priorities.” In addition, he said by email, “there is broad recognition by the patient community of the significant unmet medical needs that exists for many fighting devastating and debilitating diseases.”

National Health Council’s members from the drug industry “have the ability to provide input into the work we do, as do all our stakeholders,” Boutin said in an interview.

“We don’t speak for industry,” Boutin said. “They are in membership, but you’re never going to see us speak on their behalf.”

“We always speak from the patient perspective,” he said.

Patient groups hold 11 of 21 seats on the organization’s board, giving them control over its governance, Boutin said. Asked to what extent those patient groups have ties of their own to industry, he said, “The majority of patient groups have relationships with industry.”

Taking Attendance

POGO sought access to one of the stakeholder meetings and was refused admission. An FDA official, Steve Berman, who identified himself as one of the project managers for the PDUFA reauthorization, said the meetings were designed for specific stakeholders—patient groups and consumer advocates.

In fact, the FDA diluted the opportunity for patient and consumer advocates to have a say by opening the meetings to certain other participants. When it published a notice in the Federal Register inviting “stakeholders” to sign up for the periodic meetings, the agency included “patient and consumer advocacy groups, health care professionals, and scientific and academic experts.”

Asked what criteria the FDA used to determine who would be allowed to participate in the stakeholder discussions, FDA spokeswoman Tara Goodin said by email, “Any interested individual representing patient and consumer advocacy groups, health care professionals, or scientific and academic experts, that notified the FDA of their intent to participate, were subsequently invited to the meetings.”

The invitation did not explicitly extend to industry groups.

Groups listed in FDA minutes as having been admitted to the stakeholder discussions include, among many others:

Then there’s Cancer Support Community, whose board includes the senior director of global advocacy and professional relations at Eli Lilly, two executives from Vertex Pharmaceuticals, the chief financial officer of a medical device company, the co-head of government affairs at Goldman Sachs, the chairman of Bexion Phamaceuticals LLC, an executive at a public relations firm whose online bio describes him as “a seasoned marketing leader in the pharmaceutical and device marketplace,” and, until recently, a senior vice president for government affairs at Bristol-Myers Squibb. It also includes the chief executive of Cancer Support Community, a former overseer of patient relations at drug-maker Hoffman-LaRoche.

Cancer Support Community is successor to Gilda’s Club, which the actor Gene Wilder helped establish in memory of his wife, Saturday Night Live comedian Gilda Radner.

“I don’t know of any patient organization that does not receive some sort of funding from industry.”
— Diane Dorman, expert advisor at Catalyst Healthcare Consultants

The organization lists sponsors from the pharmaceutical industry, including sponsors of its “Cancer Policy Institute.”

On its website, Cancer Support Community says it will not accept corporate contributions that are contingent on it taking any position but will consider the views of industry sponsors.

“While we welcome input from our corporate partners, CSC maintains total independence and has ultimate authority over program design, development, content, speaker selection and/or policy positions,” the organization says.

Asked in an interview whether Cancer Support Community’s relationship with industry informs the organization’s work, CSC President Linda House, who previously worked for Lilly Oncology, said: "Patients inform the work. Period."

FDA minutes of the September 28, 2015, stakeholder meeting list another attendee, Diane Dorman, who previously served as vice president for public policy at an advocacy group called National Organization for Rare Disorders (NORD). Dorman’s LinkedIn profile says that, since May 2015, she has worked as an “Expert Advisor” at “Catalyst Healthcare Consultants,” a “boutique regulatory advisory firm.”

“Catalyst works closely with clients to anticipate and shape complex health care issues that can affect their business, and to address the FDA regulatory hurdles that can arise during the product development and approval process, including creating engagement strategies to find win-win solutions that benefit the patient, client and regulators,” Dorman’s LinkedIn profile says.

The website of Catalyst Healthcare Consulting says its clients include “biopharma” companies.

In February 2016, a consulting firm called PharmApprove issued a news release saying it had hired Dorman “to further strengthen our already-impressive roster of pharmaceutical industry experts.” PharmApprove describes itself as “the leading strategic, regulatory, and scientific communications consultancy to the pharmaceutical and biotech industries.” Part of its mission, it says, is helping clients “win health authority approvals.”

“The firm offers both strategic and tactical support to companies facing high-profile, high stakes events and engagements anywhere along the road to approval and commercialization – including FDA Advisory Committee meetings,” PharmApprove said in the news release.

Dorman said in an interview that she was not representing anyone at the PDUFA stakeholder meeting and that she has worked with Catalyst only “on rare occasions in an advisory capacity.” As part of PharmaApprove’s efforts, she said, she works with patients, members of their families, and caregivers who testify at FDA advisory committee hearings on whether drugs should be approved. She said she helps find people to testify and helps prepare them for their appearances.

“The companies themselves in some instances will pay for the patients’ transportation and hotel accommodations to get them there to the advisory committee meeting,” she said.

Asked about patient organizations’ relationships with industry, Dorman said, “I don’t know of any patient organization that does not receive some sort of funding from industry.”

“For a lot of patient organizations, that’s primarily their source of funding,” she said.

Public Meeting Panelists

Although industry groups were theoretically unwelcome at  the stakeholder discussions, the invited panelists at the August 15 FDA forum on PDUFA VI included people explicitly representing industry, such as Sascha Haverfield of PhRMA, who enthusiastically embraced the agreement.

“PDUFA VI will be critical to the integration of innovative regulatory science approaches into drug development and review, including advancing the science of patient input, as we just covered here now, facilitating the use of novel trial designs” and “patient-reported outcomes,” Haverfield said.

The panelists also included others like Boutin whose industry connections went unstated.

“I am the Associate Director of Public Policy at the National Organization for Rare Disorders. And we represent all 30 million Americans with rare diseases,” panelist and stakeholder meeting participant Paul Melmeyer said.

“So we’ve been very pleased to participate in the PDUFA reauthorization process for the last 13 months,” Melmeyer said. “And I think we see a lot of alignment within the commitment goals letter for what we were hoping to see,” he said.

On its website, National Organization for Rare Disorders says it is grateful to the companies on its “Corporate Council.”  What follows that acknowledgment is mainly a long list of drug companies.

According to NORD’s website, membership on the Corporate Council costs $10,000 to $25,000 per year.

NORD’s “Code of Conduct” for the council says NORD is “guided by its determination of what is in the best interests of the patient community” and “maintains independence in its advocacy positions and initiatives, which are formulated by senior staff, the board of directors, and NORD’s medical advisors.”

However, NORD also says that, for members of the Corporate Council, “Specific Benefits Include:”

Melmeyer told POGO that NORD’s Corporate Council is a group “that we consult at times for their opinion” on legislation and policy. The council’s role is “purely consultative in nature,” he said.

Cynthia Bens of the Alliance for Aging Research, another panelist and stakeholder meeting participant, was similarly upbeat about PDUFA VI at the FDA forum.

“We feel that our coalitions have provided a meaningful conduit to facilitating really meaningful communications between FDA and the stakeholder community,” Bens said at the August forum.

The Alliance for Aging Research board of directors includes members from Pfizer, Johnson & Johnson, EIP Pharma, Novartis, and GlaxoSmithKline, along with Billy Tauzin, former president of PhRMA. The alliance’s “Impact Report” for 2015 includes a list of “Generous Donors,” from Abbott Laboratories to National Pharmaceutical Council, BIO, and PhRMA.

Bens declined interview requests for this story.

Johnson & Johnson’s representative on the board “has not in any way spoken with the Alliance regarding its positions on PDUFA VI,” company spokesman Ernie W. Knewitz said by email. “The Alliance is known throughout government, industry and the patient advocacy community as objective, and data and fact-driven, and they maintain a related perception of objectivity and trust by decision-makers and other stakeholders,” he added.

Puppy Dogs, Rainbows, and Clouds

Not every representative who participated in the PDUFA stakeholder meetings or spoke at the FDA’s August 15 public forum had industry backing. For example, after the invited panelists had their say, members of the public were given a chance to speak. The last person to step to the microphone was Paul Brown.

“If I had to summarize today's panels and whatever everybody else has said, it’s—everyone is really supportive of the commitment letter. It's almost like, you know, puppy dogs and rainbows,” Brown said.

“However, with rainbows, you do get clouds, and I'm going to mention a few clouds.”

Brown explained that he is with National Center for Health Research, which, he said, receives no money from drug makers.

(At the outset of the open-mic session for the members of the public, the FDA moderator had asked speakers to disclose any financial conflicts. “Since we would like this to be a transparent process, we encourage you to note any financial interests that you have that are related to your comments,” moderator Pujita Vaidya said. The moderator made no such request of the invited panelists.)

“Our Center is disappointed that the focus of the FDA commitment letter is on speed,” Brown said. “User fees should focus more on improving the safety and efficacy of drugs, not just the speed of approval.”

Brown said the FDA is indirectly contributing to skyrocketing drug costs by approving products that have little if any benefit. The FDA’s agreement with industry “emphasizes a flexible approach to approving drugs” that may ultimately offer “nothing but false hope” and “risks that far outweigh the benefits,” he said.

“One final thing,” Brown added.

“I was glad to be here, glad to have the opportunity to speak. I was very disappointed that there were no consumer groups on the panels. It seemed like you used the same folks on multiple panels. I know our organization was not contacted to be on a panel. I know that National Consumers League was not. I hope that some of the other groups, such as Consumers Union, Public Citizen, US PIRG, can be involved in these discussions. I think they'll add a different point of view and a useful point of view.”

FDA spokeswoman Goodin said by email that representatives from the consumer group Public Citizen were invited but were unable to attend.

Michael Carome, director of Public Citizen’s Health Research Group, said that even if his group could have participated, it might have declined. Public Citizen opposes the user fee system as contrary to the public interest and doesn’t think participating would have made much difference, he said.  “We don’t want to do things that sort of buy into the process,” he said.

Selective Disclosure

National Health Council spokeswoman Debra Z. Roth said by email Boutin was “surprised” that a recording of the August 15 FDA meeting showed “that he didn’t list all our member categories.” She said it was a rare departure from his usual practice. She also provided a copy of a written statement by Boutin dated April 12, 2010, commenting on the last PDUFA reauthorization. The statement said the National Health Council’s members included “major pharmaceutical, medical device, and biotechnology companies,” among others.

A transcript of an FDA public meeting that day shows Boutin was less explicit about the corporate members when he delivered his remarks.

“We provide a united voice for people with chronic diseases and disabilities,” he said. “Our membership includes 50 of the leading patient advocacy organizations such as the American Cancer Society, American Heart Association, as well as many other patient advocacy organizations. We also include other membership categories and they include member organizations like the Association of American Cardiologists, as well as nonprofit organizations that deal with family caregiving and business and industry.”

National Health Council has been less than forthcoming about its corporate sponsors in another context: the debate over the 21st Century Cures Act, a bill that could lower hurdles to drug approval. Last year, it rallied other organizations to support the bill, declaring, “The National Health Council is urging the patient community to show its solidarity for H.R. 6, the 21st Century Cures Act, by signing on to the letter below.”

The letter began: “We, the undersigned organizations, represent a widely diverse community of patients and family caregivers with distinct perspectives; yet we stand united in support of H.R. 6, the 21st Century Cures Act.”

The House Energy and Commerce Committee later publicized the letter in a news release, saying, “Today, 251 patient organizations joined together in expressing their strong support for H.R. 6, the 21st Century Cures Act.”

The legislation is one of lawmakers’ top priorities in the current lame duck session of Congress.

Lexi Curnin, Daniel Van Schooten, Nick Pacifico, Joe Newman, and Halle Zander contributed to this report. Editing by Danni Downing.

Recommendations

End Reliance on User Fees. One way to enhance the FDA’s independence and help prevent the problems identified in this report would be to end the FDA’s reliance on user fees. These are direct payments by manufacturers for certain services provided to them by the FDA. In return, the manufacturers count on special consideration, including faster approvals of drugs. Often “faster” means “less careful” or “less independent.” Congress should not reauthorize the Prescription Drug User Fee Act (PDUFA). Instead, it should use federal appropriations to fund all of the FDA’s work on prescription drugs.

Eliminate Requirement for FDA to Negotiate User Fees with Regulated Industry. A short term solution and a more immediate fix to the problems described in this report would be to eliminate the legislative requirement that the FDA negotiate with “the regulated industry” in advance of user fee reauthorization.

Increase Transparency of Negotiation and Consultation Meetings. In the absence of either of the previous suggested changes, Congress should require much more transparency in the user fee reauthorization process. It should open to the public the FDA’s negotiating sessions with industry and its consultation meetings with other stakeholders, including patient and consumer groups. Congress should also require online posting of live webcasts, permanent video recordings, and transcripts of those meetings. Consumer groups that do not receive funding from the pharmaceutical or biotech industries should be included in these meetings. Transparency would allow the public and Congress to better oversee the agreements the FDA negotiates with the drug industry over the agency’s funding and its approach to reviewing drugs. It would help the public and Congress determine whether additional reforms are needed to protect public health and safety.

Require Conflict of Interest Disclosure for Stakeholders. POGO’s investigation found that the vast majority of the patient advocacy groups that the FDA consulted in the latest round of user fee meetings received funding from the pharmaceutical industry. Congress should require that all stakeholders who participate in meetings with the FDA over user fee renewal disclose all potential personal and financial conflicts of interest. Those disclosures should be posted online when the meetings take place. The disclosures should include, but not be limited to, industry funding of stakeholder groups, industry representation on the boards and staffs of those groups, and board members who serve as employees or contractors to companies in FDA-regulated businesses—e.g., makers of medical devices and contract research organizations, which manage clinical trials for drug companies.

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