Last year, based on growing concerns about the safety of certain sunscreens, the Food and Drug Administration (FDA) published a plan of action.
It proposed concluding that, for two sunscreen ingredients, the risks outweigh the benefits, and it proposed declaring that there was insufficient data to support the safety of a dozen others—for example, one that has shown up in blood plasma, amniotic fluid, urine, and breast milk.
It proposed restricting properties of spray sunscreens to reduce the risk of inhaling them and suffering lung disease, and it proposed requiring that many sunscreens meet a stricter standard for protection against ultraviolet radiation.
“While Americans were focused on a deadly plague and its devastating fallout, Congress fundamentally altered FDA oversight of thousands of drugstore items.”
It said it wanted to eliminate “potential confusion permitted by the current labeling regime,” under which a product labeled with a higher sun protection factor or SPF can provide “inferior protection” than one with a lower SPF because it filters a narrower spectrum of ultraviolet radiation.
The FDA’s proposal was apparently derailed by the coronavirus.
More specifically, by part of Congress’s response to the pandemic: the economic relief legislation known as the CARES Act, passed in late March.
While Americans were focused on a deadly plague and its devastating fallout, Congress fundamentally altered FDA oversight of thousands of drugstore items.
Little-noticed provisions of the CARES Act gave manufacturers new sway over the consumer protection agency and streamlined the process by which the FDA makes decisions about so-called over-the-counter or OTC drugs—products marketed for personal health and sold without a prescription.
Now, what the FDA does about sunscreens could become a test of the new system.
The CARES Act will force the FDA to start over on the sunscreen initiative, observers said.
How the agency follows through could reveal whether it will be compromised by industry’s new influence and whether the new streamlined decision-making system will lead to better consumer protection.
As Congress was drafting the $2 trillion bill in March to rescue America from economic collapse, lawmakers seized the opportunity to revamp regulation of a vast array of products that fill your pharmacy and convenience store shelves, such as acne creams, antacids, antiflatulents, antifungals, antihistamines, antiperspirants, dandruff treatments, pastes for diaper rash, nighttime sleep aids, wart removers, products marketed as cough and cold remedies, and lotions meant to reduce your risk of sunburn and skin cancer.
One profound change is that makers of over-the-counter drugs will pay the FDA to oversee those products. The funding comes with conditions, and it gives the industry leverage over its regulator.
Under the new law, the FDA’s power to collect the money will expire in five years, and, before Congress will renew it, the FDA must engage in “negotiations with the regulated industry.”
So-called user fees paid by makers of regulated products already fund other FDA activities, such as oversight of prescription drugs and medical devices. As the Project On Government Oversight (POGO) has reported, the fees make the agency both dependent on and beholden to the very companies it oversees.
In the realm of prescription drugs, the pharmaceutical industry has used the negotiations to extract commitments over how the FDA will use the money and to steer the agency toward alternatives to controlled clinical trials as a basis for drug approvals, a POGO investigation found.
The prescription drug user fee system has at times led the FDA to devote user fee money to commercial priorities, such as speeding the approval of drugs, instead of other public health concerns, such as policing pharmaceutical ads for false claims or tracking dangerous side-effects once drugs are allowed on the market.
“The payor of a user fee receives a benefit for having paid the fee,” the FDA noted in a 2016 slide presentation.
“The payor of a user fee receives a benefit for having paid the fee.”FDA slide presentation, 2016
While the CARES Act requires the FDA to negotiate with industry, it requires the agency to “consult” with others, such as “representatives of patient and consumer advocacy groups.” In the realm of prescription drugs, the so-called patient advocacy groups the FDA consulted the last time user fees came up for renewal generally had ties to the pharmaceutical industry, POGO’s 2016 “Drug Money” investigation found.
The FDA and manufacturers have for years been laying the groundwork for adoption of user fees for over-the-counter products. In 2016 and 2017, they held a series of meetings on the subject. Industry participants included Procter & Gamble, Bayer, Sanofi, Johnson & Johnson, and a trade association, the Consumer Healthcare Products Association.
The plan the FDA and industry developed set out “performance goals” for the agency to meet under an anticipated user fee regime, including what the document describes as “substantially shortened timeframes” for the FDA to act on requests from manufacturers of over-the-counter drugs.
“This goals document represents the product of FDA’s discussions with the regulated Industry, and consideration of input by public stakeholders,” the document, called a “commitment letter,” says.
The performance goals “are important for facilitating timely access to safe and effective medicines,” the document says.
The plan the FDA and industry developed was contingent on action by Congress. Now that Congress has acted, the FDA plans to follow the performance goals in that document, FDA spokesman Charlie Kohler said in an email to POGO.
Diana Zuckerman, president of the National Center for Health Research, said the commitment letter “does not seem appropriate.”
“Performance goals should include at least as much attention regarding evidence of safety or effectiveness as it does to the issues that industry cares the most about,” Zuckerman said by email.
Historically, industries have embraced user fees as a means of reducing regulatory delays. For Congress, getting companies to pay for regulators’ salaries has been an easier pill to swallow than spending taxpayer dollars or adding to federal budget deficits.
The new user fees will enable the FDA to increase its budget and staffing for overseeing nonprescription drugs.
In the 2016 slide presentation, the FDA said it was spending just $8.2 million a year and had the equivalent of only about 30 full-time employees to oversee “hundreds of thousands of products consumed - in many cases, on a daily basis - by millions of Americans.”
The FDA compared the $8.2 million to what it said was the $8 million cost of producing “the ‘Blackwater’ episode of the hit TV series Game of Thrones.”
According to the industry’s Consumer Healthcare Products Association, over a five-year period, the user fee program will generate more than $130 million in fee revenue for the FDA.
“Creating an efficient, modernized system requires new resources, which is why the OTC industry was willing to supplement appropriations with a new user fee program,” David C. Spangler, a senior vice president at the Consumer Healthcare Products Association, said in written answers to POGO. “We believe the fee agreement strikes the right balance and will help to achieve a more nimble regulatory structure,” he added.
“FDA will continue operating independently as the regulatory body overseeing” the over-the-counter system, he said.
“With user fees, drug makers get their money's worth.”Dr. Sidney M. Wolfe, founder of & senior advisor to the Health Research Group at Public Citizen
Dr. Sidney M. Wolfe, founder of and senior advisor to the Health Research Group at Public Citizen, a consumer advocacy organization, sees it differently.
Helping the FDA to act in a timelier fashion could be a step in the right direction, but user fees could undermine that progress by giving the regulated more influence over the regulators, he said.
“The point is, the FDA and the public health are too important to leave the FDA under the thumb of industry funding,” Wolfe said in an interview. “It is pie in the sky and an example of denial to pretend that industry funding is not going to have any effect on what FDA does.”
Wolfe’s conclusion: With user fees, drug makers “get their money’s worth.”
There’s a history, he noted.
Past or Prelude?
In 1998, several years after the FDA adopted user fees for prescription drugs, Public Citizen surveyed medical officers at the FDA to gauge the effects.
“Nineteen medical officers identified a total of 27 new drugs in the past three years that they reviewed that they thought should not have been approved but were approved,” Public Citizen wrote at the time. “Asked how they would compare the current standards of FDA review for safety and efficacy to those in existence prior to 1995, 17 medical officers described the current standards as ‘lower’ or ‘much lower,’” Public Citizen wrote.
According to Public Citizen, one medical officer gave this response: “In the last two years, I recommended that two drugs not be approved. They were both approved without consulting me. This never happened before. In one case, the drug did not meet the standards set up by the division, so they nullified the standards.”
The inspector general at the Department of Health and Human Services, in which the FDA is housed, conducted a similar survey and published its results in 2003.
“The new user fee system for over-the-counter drugs will create a conflict of interest, putting pressure on the FDA to answer more to industry and less to the taxpayer.”former FDA drug reviewer Erick H. Turner
The inspector general found that FDA employees responsible for reviewing new drugs were “under constant pressure to meet time goals” and that “workload pressures increasingly challenge the effectiveness of the review process.”
Fewer than two-thirds of the FDA respondents—64%—“were confident in FDA’s decisions regarding the safety of a drug,” the inspector general reported.
In addition, “40 percent of FDA survey respondents who had been at FDA at least 5 years indicated that the review process had worsened during their tenure in terms of allowing for in-depth, science-based reviews,” the inspector general reported.
More than one in five FDA respondents—21%—“indicated that the work environment allowed for the expression of differing scientific opinions to a small or no extent,” the report said. The FDA’s Center for Drug Evaluation and Research conducted an internal survey of its reviewers and found that “one-third of respondents did not feel comfortable expressing their differing opinions,” the inspector general’s report added.
“Overall, these findings present a significant warning signal,” the inspector general reported.
In an email to POGO, former FDA drug reviewer Erick H. Turner gave a warning of his own.
The new user fee system for over-the-counter drugs “will create a conflict of interest, putting pressure on the FDA to answer more to industry and less to the taxpayer,” Turner, now senior scholar at the Oregon Health & Science University’s Center for Ethics in Health Care, wrote.
“It will likely create regulatory capture, as the OTC Drugs Branch of the FDA becomes financially dependent on that industry sector,” Turner wrote.
The CARES Act makes it easier for the FDA to make and implement decisions about the sale and marketing of over-the-counter drugs, replacing a system criticized as slow and dysfunctional.
The monographs spell out what active ingredients are allowed and the terms under which they are allowed, such as dosages; forms of delivery, such as tablet or liquid; “indications,” meaning instructions as to what the drugs should be used for; and other labeling information, such as warnings and directions.
Manufacturers are allowed to market products that comply with the monographs.
Before the coronavirus relief legislation, both the monographs and changes to the monographs had to go through the notice-and-comment process used to adopt federal regulations. That included conducting economic cost-benefit analyses, evaluating how much paperwork they would entail, and potentially undergoing review by the Office of Management and Budget.
The FDA has been asking for a more streamlined process.
“Approximately one third of the monographs are not yet final, and several hundred individual ingredients ... do not have a final determination of safety and effectiveness.”Testimony of Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, to Congress in 2017
The agency “still has not been able to complete many monographs begun decades ago,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in testimony to Congress in 2017. “Approximately one third of the monographs are not yet final, and several hundred individual ingredients (monographs can include multiple ingredients) do not have a final determination of safety and effectiveness,” Woodcock said.
Woodcock said it took about seven years to require a new warning about potential liver injury from the pain reliever acetaminophen, also known by the brand name Tylenol.
Advocates of the latest legislation have cited the FDA’s acetaminophen history as evidence that the system was broken. But Wolfe, who served on an FDA advisory committee that studied the drug, said the agency could have acted sooner on over-the-counter acetaminophen. “They just didn’t want to do it.”
“I don't think they were hampered by the monograph system,” he told POGO.
The CARES Act allows the FDA to issue decisions about over-the-counter drugs by administrative order instead of going through the rulemaking process.
The new streamlined process includes elements of accountability. Manufacturers’ requests must be made public, the public will be given a chance to comment on pending matters, and the scientific standards that are supposed to govern FDA decisions have not been relaxed.
But the changes are a double-edged sword. By removing procedural hurdles, the new, more streamlined process will make it easier for the agency to protect consumers or to accommodate manufacturers at consumers’ expense. It will make it easier for the FDA to take action against dangerous products or to clear the way for new ones, along with new marketing claims.
An open question is how, if at all, the new user fee system for over-the-counter products will influence FDA decision-making.
Hitching a Ride
What are the odds that sunscreen prevents or cures coronavirus?
But supporters of the CARES Act provisions on sunscreens and other over-the-counter drugs say including them in the coronavirus relief bill was not such a stretch.
Drafts of the FDA-related legislation had been in a holding pattern when the pandemic struck. The House passed a bill in January 2019 on a vote of 401 to 17, and the Senate passed a version in December 2019 on a vote of 91 to 2.
“Often times you look for a vehicle that you can attach your bill to because it’s germane or somehow related,” said Mike Tringale of the Consumer Healthcare Products Association, which had been pushing for the FDA legislation. “We’ve been looking for a vehicle to attach it to,” said Tringale, the group’s vice president for communications and government affairs, “and this is the vehicle it ended up getting rolled up in.”
(Borrowing from the earlier bills, the CARES Act even gave sunscreens a place of their own in the coronavirus relief package: “SEC. 3854. Treatment of Sunscreen Innovation Act.”)
In the Senate, cosponsors of last year’s bill included the chairman and the ranking member of the health committee, Lamar Alexander (R-TN) and Patty Murray (D-WA). They guided the legislation into the CARES Act, Senate aides said. (See accompanying story, “Following the (Drug) Money.”)
Aides to Alexander and Murray said the changes could be useful in the current crisis.
Taylor Haulsee, a spokesperson for Alexander, put it this way: “Here is why this bill is relevant to the coronavirus legislation: If FDA learns that an over the counter drug may have an effect on coronavirus, for instance there are reports that ibuprofen may make coronavirus worse, this law will allow FDA to make changes to the label of that drug faster to warn consumers about any risk (or conversely any benefit if we learn something helps address coronavirus symptoms).”
A spokesperson for Murray, Helen Hare, gave a similar explanation, saying the law will “help the FDA get timely, science-driven information directly to families about the over-the-counter drugs available to them during this pandemic, as well as in future public health crises.”
The FDA’s 2019 sunscreen proposal shows the kind of questions non-prescription products can raise.
As it illustrates, sunscreens are an area in which the FDA has resisted industry pressure.
Coincidentally or otherwise, they are also an area in which the FDA has not previously received industry funding.
In February 2019, the FDA published a notice of proposed rulemaking in the Federal Register explaining how it was proposing to address a variety of sunscreen issues. If Congress had not passed the CARES Act, the proposal eventually could have progressed to a final rule resolving those issues.
In the proposal, the FDA said it was “largely focused on potential long-term adverse effects or effects not otherwise readily detected from human use,” such as “carcinogenicity”—meaning the ability to cause cancer—and “reproductive toxicity.”
The proposal called for manufacturers to provide data on the safety of a dozen sunscreen chemicals for which the agency said supporting evidence is lacking.
“For example, the available literature includes studies indicating that oxybenzone is absorbed through the skin to a greater extent than previously understood and can lead to significant systemic exposure, as well as data showing the presence of oxybenzone in human breast milk, amniotic fluid, urine, and blood plasma,” the FDA notice said. The published literature raised concerns that the exposure to the chemical could affect the endocrine system, the notice said.
The endocrine system produces hormones that control a range of bodily functions, including metabolism and reproduction.
“Nearly all of these sunscreen active ingredients … have limited or no data characterizing their absorption,” the notice said.
“Nearly all of these sunscreen active ingredients . . . have limited or no data characterizing their absorption.”FDA notice of proposed rulemaking from February 2019
The FDA proposed classifying two other ingredients as unsafe—or, more precisely, in FDA parlance, as “not generally recognized as safe and effective or [having] unacceptable indications.”
“In the case of trolamine salicylate, these risks include the potential for serious detrimental health effects (including bleeding) caused by the anti-coagulation effects of salicylic acid,” the FDA wrote.
The FDA said it did not believe those two active ingredients were currently being used in sunscreens marketed in the United States. Classifying them as unsafe could keep them out.
The agency proposed declaring some forms of sunscreen already on the market, such as wipes and body washes, to be new drugs, which would require them to be withdrawn from the market while they undergo a potentially lengthy review, and it proposed declaring unsafe or ineffective products that combine sunscreen and bug repellents.
In response to the FDA proposal, two industry groups, the Personal Care Products Council and the Consumer Healthcare Products Association, opposed the agency’s plan to require more data on the safety of the dozen sunscreen ingredients. The industry groups urged the FDA to declare the ingredients safe and effective.
“We are confident that currently marketed sunscreens are both safe and effective,” they wrote. They said they were concerned that the FDA “may be causing undue worry” and that the agency’s plan “may result in unintended negative health effects by deterring consumers from using sunscreens.”
The Consumer Healthcare Products Association and others who have followed the matter closely said the CARES Act requires the agency to drop the proposed rulemaking and proceed under the new system.
Under the new law, in place of the proposed rule, the FDA will have to issue an administrative order, Spangler, senior vice president for legal, government affairs and policy at the Consumer Healthcare Products Association, said in an interview. The administrative order doesn’t have to be the same as the proposed rule, Tringale, the association’s vice president for communications and government affairs, elaborated by email.
Scott Faber, senior vice president for government affairs at the Environmental Working Group, echoed that assessment. The “burden will still remain on sunscreen manufacturers to prove that those ingredients are safe,” he added.
POGO asked the FDA what will now become of its proposal. The FDA didn’t say.
In response to questions from POGO, FDA spokesperson Charlie Kohler provided a statement saying that the agency’s analysis of the CARES Act “is ongoing.”
“The FDA is committed to using the new tools provided in the Act to promote innovation and improve the safety and effectiveness” of over-the-counter products, the FDA said.
“We look forward to providing updates to stakeholders as we implement this important new law.”