March 8, 2013 – The Office of
Prescription Drug Promotion (OPDP) today announced that it would be restructuring two of its divisions – the Division of Consumer Drug Promotion and the Division of Professional Drug Promotion – to better oversee direct-to-consumer (DTC) advertising.
According to a memo to Center for Drug Evaluation Research staff from Center Director Janet Woodcock, this restructuring – which would rename the divisions the Division of Advertising and Promotion Review I and the Division of Advertising and Promotion Review II –will “increase efficiency, improve work distribution, and eliminate redundancy.”
Instead of placing all consumer-directed marketing materials in one division, the new structure would divide the consumer-oriented
pieces among both divisions, divided by therapeutic class. “These changes will allow OPDP to review [DTC] and health professional advertising more effectively,” Woodcock stated.
“We know that DTC advertising is often the catalyst for patients initiating conversations with their physicians about their untreated or under-treated conditions. It is also a subject of interest and debate among our stakeholders,” she wrote. “The decision to restructure the divisions reflects our commitment to continue providing close oversight of DTC advertising.”
Woodcock also noted in her memo that OPDP reviewers will continue to use “a comprehensive surveillance, enforcement, and education program to foster superior communication of labeling and promotional information to both health care professionals and consumers.”
Jan. 15, 2013 – If 2012 – with its high number of new drug approvals, senior staff stability within the FDA and the Department of Health & Human Services (HHS) and a definitive decision about the Affordable Care Act (ACA) – is an indicator, then the 2013 Washington outlook for pharmaceutical companies is promising. However, the industry must continue to monitor key issues – especially taxes and privacy – that could send dark clouds over this year, according to speakers at the Jan. 9 Coalition for Healthcare Communication policy update meeting held in New York.
Kate Rawson, contributing editor at Prevision Policy, told meeting attendees that the agency’s record number of new drug approvals – 39 in 2012 – is clearly a plus for pharma. Further, under a new FDA drug approval program, which focuses on novel drugs with more meetings and additional transparency, the prospects for new drug candidates is “as good as it gets,” Rawson said. The FDA Safety and Innovation Act (FDASIA) also provides incentives for antibiotics, a biosimilar pathway, resources for generic drug reviews and a focus on the supply chain.
Further, the U.S. Supreme Court decision on the ACA is generally positive for pharma companies, Rawson indicated, both because it resolves the uncertainty around ACA implementation and, according to Centers for Medicare & Medicaid estimates, should boost drug spending by 2014. However, Rawson added that states may opt out of Medicaid expansion and noted that the impact of the ACA-mandated Independent Payment Advisory Board (IPAB) – a 15-member board that will determine what Medicare will pay for and where cuts should be made – remains unclear. The evolution of the as-yet-unnamed board is an issue that industry “definitely needs to keep an eye on,” Rawson said. [See Rawson's slides for more information.]
And, although a new Congress is in place, it is facing many of the same fiscal challenges as the previous Congress, according to Coalition Executive Director John Kamp. “Policy wonks, Wall Street and Washington all remain focused on debt, the economy, sequester deadlines and tax cuts,” he said. “Tax and spending policy changes define the battles, but mostly it is a question of how quickly lawmakers will reduce the deficit and how deep the cuts will be. There is incredible pressure to avoid cuts in defense, Medicare and
Social Security, so this is a very dangerous time for any tax expenditure, including the deductibility of marketing.” Industry experts fear that significant tax code reform in 2013 is inevitable and could affect the medical marketing tax deduction. “The danger cannot be ignored. No tax idea, good or bad, goes away,” Kamp said. “Every time a Senator or a member of Congress needs several extra billion dollars, our industry will be at risk.”
Pharma companies also need to track any privacy legislation coming out of this Congress, Kamp advised. Many policymakers are pleased with the progress of industry self-regulation of data collection, but others, including Sen. Jay Rockefeller (D-W. Va.), chair of the Senate Commerce Committee, appear committed to legislation that would give the Federal Trade Commission greater power to require consumers to “opt in” before data collection, even for information that does not identify a specific person.
A topic carried forward from 2012 is the impending issuance of the final “Sunshine Act” rules, which will make transparent any payments provided by industry to physicians. In its comment to HHS on the proposed rules, the Coalition stated that HHS must enable industry to provide context and verify the accuracy of payment reports to ensure that the public, the press and policymakers understand the purpose and public health value of industry-physician collaborations, Kamp explained. Another issue to watch in 2013 is how the FDA responds to the U.S. Second Circuit Court of Appeals decision in U.S. v. Caronia, which states that truthful, nonmisleading communication between sales reps and physicians is speech protected by the First Amendment and cannot be used as evidence of misbranding. “The decision in this case undermines the regulatory basis for all FDA marketing enforcement and most HHS IG/state ‘false claim’ settlements,” Kamp told Coalition meeting attendees. [See Kamp's slides for more details.]
With all of these areas to focus on, “2013 will be an interesting year for the pharma industry, and there is no better time to become more actively engaged to preserve the true purpose of medical marketing: getting truthful information about treatments out to physicians and their patients,” Kamp said.
June 26, 2012 – The FDA’s Risk Communication Advisory Committee is meeting Friday, June 29, to discuss recent research on communicating and understanding uncertainty, as well as
risk perception in low-income populations with multiple risks.
According to discussion topics for the meeting issued by the agency, the RCAC would like to get answers to the following questions:
The RCAC meeting will be held at FDA’s White Oak Campus (10903 New Hampshire Avenue., Bldg. 31, Conference Center Room 1503, Silver Spring, MD), from 8 a.m. to 3:30 p.m. The meeting also can be viewed remotely by logging on to: https://collaboration.fda.gov/rcac/.
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.”
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.
March 26, 2012 – Note to Industry Leaders
The Coalition for Healthcare Communication needs your input on a study FDA is planning to conduct regarding corrective DTC television advertising. In the recent past, FDA has used this enforcement tool only sparingly, most notably as part of a Warning Letter involving contraceptives. Our primary concern is that FDA may be fielding this study to support more extensive use of this extraordinary remedy.
FDA has asked for comments on the following corrective advertising study issues:
- Whether the study is necessary
- Whether the cost estimates are accurate
- Ways to enhance the study
- Ways to reduce the cost
To inform the Coalition comment to FDA, we would like to hear from you on the impact of corrective ads, especially on whether or not corrective ads achieve the intended goals of the FDA and whether or not they may be counterproductive. We would like to include data supporting our comments and recommendations wherever possible.
Corrective advertising was born in the 1970s as a hypothetical remedy for deceptive advertising. The Federal Trade Commission requires it only in extraordinary cases because it is controversial and is subject to limits under the First Amendment. At FDA, corrective advertising has been used in both professional and consumer advertising, but there exist very limited public data on its impact.
FDA’s Stated Objective
To examine how variations in corrective advertising may impact consumer understanding.
FDA proposes to use an Internet panel asking questions online. There would be two phases:
- Phase 1 – Examination of the impact of exposure to combinations of the original and corrective ad.
- Phase 2 – Examination of how the similarity of the original and the corrective ads and the time between their use impact the ability to correct misinformation.
FDA says that there will be no capital or operating and maintenance costs associated with this collection of information.
What You Can Do
If you want more details on the plan, go to the Federal Register/Vol. 77, No. 40 published Feb. 29, 2012. You may wish to pass this message along to those in your organization who focus on market research, requesting comments and suggestions.
Agencies and publishers may choose to comment individually, as well as to support the Coalition comment.
For our part, we are seeking data and information from communication professionals on just how FDA’s use of
corrective advertising action might impact consumer perception and behavior. The FDA would be especially interested in data that demonstrate the limits and possible unintended consequences of requiring corrective advertising in its enforcement actions.
Comments must be filed with FDA by April 29, 2012. We would like your views and suggestions by April 6th so we can consolidate and prepare our final comments. Interested members should contact Jack Angel at firstname.lastname@example.org or 203-661-3314.
In addition, you will soon receive a similar request to support Coalition comments on the recently released draft guidance on pre-review of DTC advertising. That comment is due May 15.
Jack Angel & John Kamp
Coalition for Healthcare Communication
March 13, 2012 – Draft guidance released today by the FDA – “Guidance for Industry Direct-to-Consumer Television Advertisements” – calls for drug sponsors to submit nearly all direct-to-consumer (DTC) television ads for review 45 days prior to dissemination and specifies the documentations needed for all new advertising claims.
The draft guidance describes the full array of DTC TV ads the FDA intends to make subject to a pre-dissemination ad review provision mandated by the Food and Drug Administration Amendments Act of 2007. It also explains how the FDA will notify drug sponsors that an ad is subject to the program and sets out procedures sponsors need to follow in order to be in compliance with the provision.
“Maybe it’s a good thing that the longtime ‘voluntary’ pre-review system is now official, but there is no good news here for patients who want speedy access to information about new medicines,” explained John Kamp, Executive Director of the Coalition for Healthcare Communication. “This law and draft guidance in effect create a ‘45-day shot clock’ that blocks information to doctors and patients about new drugs. Moreover, there is no ‘overtime’ added to the patent period to make up for these delays,” he said.
In fact, Kamp points out that these draft procedures appear to impose a new set of mandates on drug sponsors, including the submission of background information and documentation that substantiate the claims in submitted TV ads, including annotated references that are cross-referenced to the ad’s storyboard.
Agencies and clients are urged to review this guidance carefully and submit comments directly or through the Coalition by the May 14 deadline.
Long List of Ads Subject to Requirements
According to the draft guidance, sponsors must submit TV ads for pre-dissemination review if they fit in the following categories:
- Category 1: The initial TV ad for any prescription drug or the initial TV ad for a new or expanded approved indication for any prescription drug;
- Category 2: All TV ads for prescription drugs subject to a Risk Evaluation and Mitigation Strategy (REMS) with elements to assure safe use (see section 505-1(f) of the FD&C Act);
- Category 3: All TV ads for Schedule II controlled substances;
- Category 4: The first TV ad for a prescription drug following a safety labeling update that affects the Boxed Warning, Contraindications, or Warnings & Precautions section of its labeling;
- Category 5: The first TV ad for a prescription drug following the receipt by the sponsor of an enforcement letter (i.e. a Warning or untitled letter) for that product that either cites a TV ad or causes a TV ad to be discontinued because the TV ad contained violations similar to the ones cited in the enforcement letter; or
- Category 6: Any TV ad that is otherwise identified by FDA as subject to the pre-dissemination review provision.
Without specifically saying so, this list includes nearly all types of TV ads that drug companies would run, except for ads that are just remixes of the same basic information, with no new claims or changes.
Further, Category 5 forces sponsors that receive an enforcement letter for a TV ad to continuously submit TV ads – whether or not they include new information – for pre-dissemination review.
The draft guidance states that the FDA will notify drug sponsors of the requirement to submit their ads for review in the following ways: in letters approving future applications or supplements, in a labeling update, in an enforcement letter or “in other correspondence.” Already approved product sponsors falling into Categories 1, 2 or 3 will be informed of the requirement through Federal Register notices, the draft guidance states.
However, the agency also states that the onus is on sponsors to determine whether their ads fall into any of the six categories slated for pre-dissemination review, adding that “dissemination of a television ad without complying with [the provision] is a prohibited act” which can be enjoined and is subject to criminal penalties and potential civil monetary penalties.
Pre-dissemination Package Requirements
The pre-dissemination “review package,” to be submitted 45 days prior to
dissemination, must include:
- A cover letter that:
- Provides the following subject line: Pre-Dissemination Review Package for a Proposed TV Ad for [Proprietary Name/Established Name (dosage form) (for drugs), or Trade name/Proper name (for biologics)] Subject to 503B of the FD&C Act Includes the NDA or STN number
- Provides the name of the proposed TV ad
- Lists the contents of the pre-dissemination review package and the number of copies provided of each item contained in the pre-dissemination review package
- Provides a sponsor contact’s name, title, address, phone, fax, and email
- Annotated storyboard of the proposed TV ad to show which references support which claims
- The most current FDA-approved prescribing information (PI) and, if applicable, the FDA-approved patient labeling or Medication Guide with annotations cross-referenced to the storyboard
The guidance also states that a sponsor should include other appropriate documentation, if any of the following apply:
- Annotated references to support product claims not contained in the PI, cross-referenced to the storyboard
- Verification that a person identified in a TV ad as an actual patient or health care practitioner is an actual patient or health care practitioner and not a model or actor; and/or verification that a spokesperson who is represented as a real patient is indeed an actual patient; and/or verification that an official translation of a foreign language TV ad is accurate
- Annotated references to support disease or epidemiology information, cross-referenced to the storyboard
- A video of the TV ad in an acceptable format, if available. 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. 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.
“Industry must speak up,” Kamp said. “The FDA must be made aware of the practical impact of these proposals, and we must give them alternatives that are consistent with the statute but that also provide doctors and patients with speedy access to information.” Agencies and publishers interested in participating in the development of the Coalition’s comments are urged to contact Jack Angel; email@example.com.
March 5, 2012 – In a case that highlights First Amendment limits to FDA regulation of marketing, the U.S. District Court for the District of Columbia granted a motion for summary judgment Feb. 29 in favor of five tobacco companies who called unconstitutional an FDA rule requiring that new, mandatory graphic images be added to specific textual warnings included on cigarette packaging.
“The Court concludes that these mandatory graphic images violate the First Amendment by unconstitutionally compelling speech,” U.S. District Judge Richard J. Leon wrote in the court’s opinion (Civil Case No. 11-1482 (RJL)).
“If courts refuse to allow this sort of regulation of tobacco products, which cannot be used safely, it’s fair to assume that many other FDA regulations governing speech are at risk. The court’s decision reminds us that the bar for restricting speech is high,” said John Kamp, Executive Director, Coalition for Healthcare Communication.
“While the tobacco regulations were unprecedented, if the FDA can’t get tobacco restrictions past the courts, how can it possibly continue to restrict medicine companies from telling the truth about the off-label uses of their products?” Kamp continued.
The tobacco companies successfully argued that the congressionally mandated graphic warnings unconstitutionally compel speech, “and that such speech does not fit within the ‘commercial speech’ exception” allowing certain types of government-mandated, informational disclosures. In legal terms, the court decided that these mandated warnings had to be analyzed under the “strict scrutiny” test of First Amendment law and that the rules failed that standard.
Stating that the FDA rule’s graphic-image requirements are not the type of purely factual disclosures that are reviewable under a less-stringent standard, the court found that the FDA failed to satisfy the burden of demonstrating that its rule is narrowly tailored to achieve a compelling government interest and, thus, violated the First Amendment.
“While the line between the constitutionally permissible dissemination of factual information and the impermissible expropriation of a company’s advertising space for Government advocacy can be frustratingly blurry, here the line seems quite clear,” the opinion states.
In light of the court’s decision, “it’s fair to ask how the increasingly intrusive ‘fair balance’ disclosures would fare under the ‘compelled speech’ theory applied in this case,” Kamp said. “Even more importantly, it’s time for the industry to ask whether the compelled disclosures do more harm than good to the public health.”
Feb. 13, 2012 – Dr. Robert Temple, the unofficial dean of drugs at the FDA, recently addressed one of the most perplexing issues in the post-health reform era – industry’s ability to fully participate in policy and pricing discussions on comparative effectiveness research (CER).
Companies are well aware that false or misleading CER findings can adversely affect their drugs’ prospects and this issue is becoming even more important as the federal government begins to fund more than a billion dollars of CER. However, some companies may believe that challenging CER findings is not allowed under FDA advertising and promotion regulations.
However, according to “The Pink Sheet” Daily, Temple, the Center for Drug Evaluation and Research deputy director for clinical science, said at a Feb. 9 conference that the FDA’s regulations do not preclude companies from challenging CER results that are false or misleading.
“Thank goodness Bob understands the problem and blasted open Pandora’s Box,” said Coalition Executive Director John Kamp. “Bob’s opinion is important, but not the last word, nor is it the opinion of most industry lawyers. The industry needs an official signal from the FDA that its participation in these discussions is appropriate and consistent with FDA marketing regulations.”
Temple said that FDA does not hold a view “that drug companies are condemned to silence about their products outside of formal promotion or perhaps published articles. If there’s something published that seems wrong, is based on poorly designed meta-analysis and so on, I don’t see any impediment to answer that and companies do answer that all the time.”
Temple did also note that companies must ensure that any rebuttal of CER findings are not promotional in nature, and that they should simply offer information and education about a product that is true to the product’s approved labeling.