(This is the first in a two-part blog. Read tomorrow when we look at how industry and other stakeholders weighed in.)

How clear does risk information need to be in direct-to-consumer drug ads? That’s the question the FDA is getting closer to answering as stakeholders weighed in this week on the agency’s proposed rules for presenting risk in broadcast ads.

Twenty-two members (see end of the blog for a complete list) of Community Catalyst’s Prescription Access Litigation Coalition and other supporting groups joined PAL in submitting comments that support the agency’s new proposal to make risk information clear, conspicuous, and neutral in TV ads. The groups also suggested the FDA require that risks be quantified in ads and that the overly-scientific talk be toned down to match the comprehension of the viewer who would have the most trouble understanding the ad.

Many of the provisions in this year’s proposed rule do reinforce the handling of risk information that FDA proposed in last year’s draft guidance. But they are clearer and more concrete, and would go further than the agency’s current standard of “fair balance,” in which drugmakers are only required to present risk as clearly as they present benefits. Specifically, the proposed rules would require that ads use everyday language that is easily readable when in writing and is presented slow enough and prominent enough, whether in writing or audio form, to be easily understood by a consumer viewing the ad. The FDA also proposed a rule that would ban any distracting sounds or images in broadcast prescription drug advertisements.

A step back on why all this matters: remember that the U.S. is one of only two countries that allows drugs to be advertised on TV at all (New Zealand is the other).  And it’s a relatively recent allowance—only in 1997 did the loosening of an FDA regulation about how the major statement about a drug is presented open the floodgates to the sleep butterflies, allergy bees, and PMS symptom balloons.

As was shown by the PAL cases on Vytorin-Zetia, Nexium, Vioxx and Ketek, those changes came with controversy and human costs. Rofecoxib, or Vioxx, was heavily advertised to consumers and physicians in its first year before it was pulled from market after being linked to between 35,200 to 52,800 deaths and 88,000 to 140,000 heart attacks in the US. This caused the Institute of Medicine and other experts to call for an end to DTCA for new drugs, whose side effects are often not known (or in Vioxx’s case, suppressed) until years after they appear on the market.

The link between DTCA and increased prescribing of newer, less-tested drugs has been well-documented, and policymakers, regulators and academics have all expressed concern that the FDA’s inability to regulate and oversee broadcast ads has put the public’s health at unnecessary risk.

But despite this concern and growing evidence that drug ads carry risks beyond the speed-read ones, drug companies came up short on proving public health benefits to their current ad style or offering new evidence-based ideas for presenting risk info in a clear and neutral way. We’ll take a look at what they said tomorrow. Short of all out banning DTCA, the FDA must determine the appropriate standards to best protect the public.

What else could the FDA do?
In addition to offering support to the proposed rules, PAL suggested additional steps that could further enhance the clarity of ads and thus further protect consumers. PAL urged the FDA to address the widely-held myths that the FDA approves all TV ads, and that the government only lets drugs that are “really safe” be advertised on TV, by requiring a disclaimer that “FDA has not approved this ad” for all ads that have not been pre-approved, and including the adverse event hot-line “Medwatch” number in all TV ads.

Though PAL fully supports FDA’s increased vigilance in regulating prescription drug ads, we noted in our comments that there are far more new ads being produced than there are FDA staff members to review these ads. It’s a big imbalance, and though increased funding and staffing of the FDA would help, delayed warning letters that appear long after an ad-buy—such as this Lunesta one–will probably still happen.

To address this issue, the FDA should start using their authority to fine drug companies for ads that violate FDA regulations. Though fining will not increase the speed at which the FDA is able to review ads, it could potentially increase pharma’s compliance with these regulations and exact a price from noncompliant companies, even if the ad in question is no longer being aired.

Those joining Community Catalyst’s and PAL’s comments were:

The Alliance for Retired Americans
The American Federation of State, County and Municipal Employees (AFSCME)
The American Medical Student Association (AMSA)
Breast Cancer Action
California Alliance for Retired Americans (CARA)
CALPIRG
The Coalition of Wisconsin Aging Groups
Connecticut Center for Patient Safety
Connecticut Citizen Action Group
Consumers Advancing Patient Safety (CAPS)
Health Care for All
IUOE Local 4 Funds
Long Island Health Access Monitoring Project
MASSPIRG
New England Carpenters Health Fund
National Legislative Association on Prescription Drug Prices (NLARx)VPIRG
National Women’s Health Network
Oregon Health Action Campaign
Prescription Policy Choices
TeamstersCare
US PIRG

–Emily Cutrell, Prescription Access Litigation

Yesterday, the FDA unveiled ‘FDA Basics’, a website tool geared to help the public get to know the FDA staff and what they do. The website will provide explainers to questions about what the agency and its different centers do, videos and profiles of agency leaders, as well as hosted online conversations between FDA officials and the public.

FDA Basics is the first of a three-part transparency initiative that the agency is undertaking under the Obama administration.  In a webinar Tuesday, deputy commissioner Joshua Sharfstein said the Basics site grew out of unsolicited public feedback to the transparency task force seeking more info about how the agency works.

But the site won’t offer the clinical safety and efficacy information on specific drugs that many consumer advocates have called for. That, Sharfstein said, is part of daunting phase two, in which the agency will make recommendations about what information should be made public and accessible  and how — including clinical trials information, recalls, approval and warning letters, and post-market surveillance.  Recent reports (see our blog last week) have highlighted the unavailability of this information to prescribers and the public–even about some of the top-prescribed drugs in the U.S.

Phase three will establish how the agency interacts transparently with regulated industries.

Sharfstein commended the tremendous feedback the agency received on the FDA transparency blog and at the task force’s public hearings, and invited more on the FDA Basics website. In response to a webinar question, he also said that the site should provide information about how to become an advisory committee member for the agency.

Check out FDA Basics here.

–Kate Petersen, PostScript blogger

In recent weeks, two communications to-dos at federal agencies illustrate the good, the bad, and the ugly when government tries to talk to its people about less-than-ideal stuff.

The good: The formation of an FDA risk communications panel by recommendation of the Institute of Medicine and provision of the FDA Amendments Act of 2007.
The bad (and ugly): A fake press conference held by the Federal Emergency Management Association during the California wildfires to promote the fact that it’s handling of the fires was not at all the botched job it became famous for in the aftermath of Hurricane Katrina.

But the FEMA news briefing — to which reporters were invited only 15 minutes in advance and then allowed only to listen to questions asked by what turned out to be FEMA staff — was evidence of the contrary, and just one more foible for the much-maligned agency, which found itself right back in the public stockades.

Unlike the fake news conference, the risk communications panel seems an earnest effort by the Food and Drug Administration to better inform the public of drug safety risks in a post-Vioxx world, where more drugs are coming from more sources than ever before and risks associated with widely-prescribed drugs are being discovered too late in the game.

William Vaughan, a committee appointee and senior policy analyst at Consumers Union, said that the advisory committee, which is scheduled to meet first in 2008, has a full plate.

“Between the new law’s requirements for how to convey adverse events in clinical trials, and the ‘study’ of how to add 1-800 number information to DTC ads (due in March 2008), I think the first year will be busy,” said Vaughan by email.

Self-declared fake news (a la The Daily Show and Colbert Report) has its place, but fake news-making paraded as real inquiry and open forum does not. Risk communication, on the other hand, is a crucial component of a good public health program. We’re all for it.

But recent reports – that the FDA reviews a small percentage of imported drugs, that it’s oversight of clinical trials is in shambles, and that post-market surveillance is hardly systematic — leave one wondering if the FDA knows enough about the risks it’s encountering to communicate them effectively.

Regardless, both announcements — one promising, one farcical — point to a serious effort to get the sound bytes right.  The prickly side of public relations — how the government talks to the people its charged with protecting about things it can’t necessarily protect them from — has taken on great importance in the Information Age and seemed recently to sometimes supersede the securing of the protections themselves.

One hopes that the advisory committee can develop ways to do both – effectively communicate food and drug risks to the public as the agency builds better safeguards and systems of surveillance and regulation. But one note of caution: Section 917 of the FDA Amendments Act, which outlines the purview of the risk communications advisory committee, calls on it to “partner with professional medical societies, medical schools, academic medical centers, and other stakeholders to develop robust and multi-faceted systems for communications to health care providers about emerging postmarket risks.”

And this could turn out good: those listed stakeholders have the potential to be valuable contributors to a better communication of drug and food risks.

Or it could be bad and ugly, since recent reports have shown many of those institutions to be rife with corporate dollars — especially dollars that come from drug and device makers.

By explicitly involving academic medical centers and medical specialty societies in this communication process about drugs that pose risks, the FDA should also be explicit about requiring full disclosure of the conflicts of interest those contributors bring to the table, or better yet, do its homework and only consult med schools and societies that have strong conflicts-of-interest guidelines in place.

As for “other stakeholders,” one can only wonder whether that’s a euphemism for industry.