April 30, 2012 – Comments are due May 7 on an FDA-proposed paradigm that would allow the agency to approve
certain drugs – that would otherwise require a prescription – for over-the-counter (OTC) distribution under “conditions of safe use.”
An FDA statement regarding expansion of the definition of nonprescription drugs says that the agency believes that some doctor visits can be eliminated under the new paradigm to remove cost or time barriers that may deter consumers from receiving appropriate medications.
“We applaud the FDA for jump-starting a public conversation about how to get medicines into the hands of people who need them with adequate directions for safe and effective use,” said Coalition for Healthcare Communication Executive Director John Kamp. “Public and targeted communication will be key to success. The stakes are high because success here means better health for individuals and better public health outcomes.”
According to Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, OTC drugs have had great success in providing consumers with excellent self-care options. “But our concept of self-care is limited to conditions that can be self-diagnosed and self-treated based on the information in the drug facts box, combined with common knowledge. What we are asking is, should there be more flexibility in the concept of nonprescription drugs? Can we broaden the assistance a consumer gets and increase the types of medicines that might be available over-the-counter?”
The new paradigm would ensure safe and appropriate use by applying special conditions to types of nonprescription products. “For example, before getting a medication, you might have to talk with a pharmacist, or need to have a diagnostic test,” the FDA states. “In other cases, you might have to visit a physician to obtain the original prescription, but not to get refills. FDA is also considering whether some drugs could be a prescription drug and a nonprescription drug with conditions of safe use.”
Among many questions cited in a call for comment published in the Feb. 28 Federal Register, the agency has requested input on the feasibility of this initiative, and what types of evidence would be needed to demonstrate that certain drugs could be used safely and effectively in an OTC setting. The agency also has requested input on dual availability of drugs by prescription and OTC and whether diagnostic tests would need to validated for a change in setting, such as in a pharmacy.
The agency lists a number of potential benefits for consumers from this initiative: an increase in the appropriate use of medication, decreases in health costs, greater access to health screening, easier access to needed medications, and better, more consistent treatment of common conditions. Major challenges with the proposed paradigm shift include reworking FDA rules and separating patients from appropriate medical care. Other potential challenges are: liability concerns, disruption of workflow for often overburdened pharmacists, equipment costs, and questions about health insurance reimbursement.
Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest, said on DrugWonks.com that some questions still remain regarding this proposal, such as: “How will this impact patient compliance? How will this affect one condition masking another, more serious one? How will this change the role of the pharmacist?”
“Hopefully stakeholders will share their views on this proposal so the FDA has the information it needs to consider this option,” Kamp said. “Regardless of the outcome here, FDA is to be commended for thinking outside of the box.”
April 23, 2012 — The House and Senate both issued draft legislation last week to reauthorize the Prescription Drug User Fee Act and with mark-ups imminent, Congress appears to be on track for passing the PDUFA V legislation by mid-year.
“The news from Capitol Hill on PDUFA V reauthorization of the FDA is great,” said Coalition for Healthcare Communication Executive Director John Kamp. “Even in the face of federal deficits, members of Congress understand that FDA must have the people and resources necessary to carry on its business, including approving drugs. Indeed, the discussions are months ahead of previous such debates, enabling possible passage well before the election recess and avoiding distracting layoff contingency plans by agency heads.”
In addition to provisions for user fees for drugs and devices, the discussion drafts from the House and the Senate address fees relating to generic drugs and biosimilar biological products as well as protection for the drug supply chain.
The draft Senate bill, “The Food and Drug Administration Safety and Innovation Act,” includes a provision creating a new review channel for breakthrough treatments and includes the Generating Antibiotic Incentives Now (GAIN) Act, which would extend the market exclusivity period for drugs treating antibiotic-resistant pathogens by five years.
The draft House bill also incorporates the GAIN Act and adds a six-month extension for any therapies approved with a companion diagnostic. Both the Senate and House drafts include provisions that would require the FDA to track drug shortages.
Further, the House legislation includes language that would permanently authorize two laws that provide incentives for conducting clinical trials for pediatric therapies: the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. Separate legislation covering this issue was introduced in the Senate and most likely will be integrated with PDUFA V during mark-up.
Interestingly, what is not included in the bills so far is any specific drug marketing language, despite consumer and other groups pressing for this during the FDA phase of the legislation process. During a Feb. 1 House Energy and Commerce Committee Subcommittee on Health hearing to discuss PDUFA V issues, medical marketing was raised in only one exchange, between Rep. Jan Schakowsky (D-Ill.) and Commissioner of Food and Drugs Margaret Hamburg, M.D.
In that exchange, Schakowsky inquired about the agency’s resources to monitor direct-to-consumer (DTC) advertising. Hamburg stated that although advertising was considered in previous PDUFA negotiations, “it is not a part of PDUFA V.”
Efforts by the Pharmaceutical Care Management Association (PCMA) to suppress the use of branded drugs and eliminate advertising tax deductions and by
consumer groups to add marketing rules to PDUFA V – including expanded capacity for DTC monitoring – to date have not yielded results in the legislation.
“But the devil is in the details,” Kamp said, “and last-ditch efforts to revive these issues could emerge during the mark-ups. We must continue to track the progress of the legislation carefully and be prepared to explain the value of drug marketing to U.S. patients.”
April 16, 2012 – The Coalition for Healthcare Communication (CHC) and The Advertising Coalition (TAC) recently told the FDA’s Office of Prescription Drug Promotion that a recent FDA study of “dual modality” risk disclosures does not support an FDA policy requiring both audio and text disclosures in all TV ads.
“Although TV ads for drugs should not be misleading, the already-extensive disclaimers imposed by FDA can be confusing and counterproductive,” said CHC Executive Director John Kamp.
“Adding a ‘dual modality’ requirement would make the problem worse, not better,” he said.
The CHC and TAC Comment to FDA was prepared in response to a Jan. 27, 2012, notice in the Federal Register. In the notice, the FDA stated that although the comment period on the proposed rule regarding the presentation of the major statement in TV ads closed June 28, 2010, it was reopening the comment period on specific data covering the impact of distraction on consumer understanding of risk and benefit information in DTC prescription drug TV advertising.
FDA analysis of the data from a study entitled, “Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements,” found that “presenting risk information at the same time in text and in audio improves consumers’ understanding of the risk information,” the notice stated.
However, CHC and TAC contend in their comment that the study does not provide support for the FDA “to venture into the creative design and formatting of advertising in a manner that would mandate a new regulatory standard that would require sponsors of television advertisements to communicate the major statement simultaneously in both audio and visual portions of the advertisement.”
Further, a dual modality requirement “would approach if not cross the important demarcation between prior restraint of advertising and a post-publication assessment that a particular ad is untruthful or misleading,” according to the comment, especially “in the context of nearly four decades of decisions by the United States Supreme Court that have extended the protection of the First Amendment to commercial speech.”
April 12, 2012 – The Association of Clinical Researchers and Educators (ACRE) announced yesterday the publication of a study in Nature Biotechnology
showing that top-tier medical journals focus on the “supposed problems from academic-industry interactions and not on the benefits,” which results in a bias against such interaction. According to an ACRE press release, the study demonstrates that “there is scant original evidence supporting claims that the industry-physician relationship is harmful to patients as is often reported in the top four medical journals.” To read more, go to: http://www.prlog.org/11847021-study-finds-high-impact-medical-journals-guilty-of-anti-industry-bias.html
By John Kamp
April 9, 2012 – The only thing really clear about the new guidance on pre-review of the DTC advertising is that advertisers and their marketing agency partners will need to ensure that their FDA submissions include detailed claims substantiation for every ad submitted. Beyond that, the analysis and commentary on the FDA guidance ranges from “not much new here” to near hysteria.
In fact, my first reaction – suggesting new, extended review delays as well as pre-reviews of virtually all TV ads – was likely an over-reaction. Most importantly, industry has been submitting most ads for pre-review under the PhRMA self-regulatory code for several years, making many of the FDA requirements old hat for industry. Indeed, the draft guidance implements requirements of the last PDUFA reauthorization, Food and Drug Administration Amendments Act, largely supported by industry and trade associations.
Regardless, seldom have I seen such a broad divergence of views on the meaning, scope and impact of a draft guidance from FDA marketing officials.
Although a first reading of the draft guidance appeared to affect nearly all DTC TV ads, the FDA recently responded to an article in “The Pink Sheet” DAILY that its pre-dissemination review policy would involve only 25 percent of DTC TV ads. Thomas Abrams, head of the FDA Office of Prescription Drug Promotion, told the publication that the 75 percent of ads excluded from pre-review “consist of TV ads for products that were already advertised on TV and do not fall into any of the categories stipulated in the guidance.”
In spite of that response and in light
of the guidance’s inclusive list of ad categories subject to submission to the FDA, veteran FDA attorney Arnold Friede believes that drug sponsors will find it difficult to identify TV ads that would not require pre-review, especially because of the “catch all” category defined as “any TV ad that is otherwise identified by FDA as subject to the pre-dissemination review provision.”
In a recent article in InsideHealthPolicy.com, Friede stated that the guidance “is in line with FDA’s ‘desire to control prescription drug promotion,’” and that its de facto prior approval for TV ads raises “some pretty serious statutory issues and constitutional issues.” However, in spite of the clarification by FDA on the scope of the draft guidance, regulatory and legal experts still may counsel clients to err on the side of caution and submit nearly every ad.
I suspect the draft guidance will spark some interesting comments. Indeed, the guidance may be challenged under a provision in the FDA statute limiting pre-reviews, or perhaps even more dramatically as a violation of the “prior restraint” limit on speech under the First Amendment.
And then there are the substantiation requirements. The content of the dossier that the agency is requesting sponsors to submit is much more comprehensive than in the past, even though such data is routinely compiled by companies for internal purposes.
Although there is some debate on the details of the new requirement, the draft guidance calls for the substantiation package to include an annotated storyboard of the proposed TV ad to show which references support which claims. However, the agency specifically states that the storyboard alone cannot be evaluated by the FDA to determine whether a TV ad is acceptable.
“The FDA cannot provide final comments on the acceptability of a TV ad without viewing a final recorded version in its entirety. FDA understands that some sponsors may wish to receive comments from the Agency before producing a final recorded version of the ad,” the draft guidance states. “In such situations, sponsors can submit a pre-dissemination review package without a final recorded version of the ad, but once the final recorded version is produced, it will need to be submitted to the Agency for pre-dissemination review.”
This could create a very difficult choice. Either submit story boards and risk that FDA will fault the final version, or produce the ads ahead of the pre-review and risk repeating the time and expense of the production.
For most companies, the process for having ads vetted by the FDA will include the following steps, according to Bruce Grant, Senior Vice President, Strategy, DigitasHealth:
(1) Submit pre-production concepts for advisory comments
(2) Produce the spot incorporating FDA comments
(3) Submit the finished spot plus the “substantiation package” for pre-dissemination review
(4) Wait 45 days, during which hopefully you will receive any additional comments back from FDA
(5) Re-submit the spot to FDA with Form 2253 and traffic to air.
This process adds another layer to the TV production workflow, but “incorporating FDA advisory comments from pre-production review should substantially mitigate – though not eliminate – the risk of unexpected comments coming out of the 45-day pre-dissemination review,” Grant said.
A potential and perhaps likely glitch is that the FDA draft guidance does not list a time frame in which the agency would provide pre-production advisory comments.
Bottom line, industry should review the draft guidance very carefully and send its comments on the areas it perceives to need revision as soon as possible. The FDA really needs to understand the impact of this document on both the advertisers and the patients they are trying to reach with valuable information about new treatments for their health conditions. The deadline for comments is May 14. Agencies and publishers wishing to assist in formulating the Coalition’s comments should immediately contact Jack Angel at email@example.com.