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.”
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 jeangel@cohealthcom.org.
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.
Background
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.
Study Design
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.
Deadline
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 jeangel@cohealthcom.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; jeangel44@yahoo.com.
March 8, 2012 – Fifteen trade associations – including the Coalition for Healthcare Communication – sent a letter to Congressional leaders this week asking them to hold off on pursuing consumer privacy legislation while industry-led self-regulatory program efforts take hold.
Because these efforts are an efficient and effective way to protect consumer privacy interests, the groups are concerned that new legislation “could undermine future efforts for successful voluntary practices,” according to the Industry Letter to Leadership re Privacy Legislation, which was delivered to all members of the House Energy & Commerce Committee and the Senate Commerce and Judiciary Committees.
“Contrary to many press reports, the industry opposes legislation at this time. Instead, Congress should acknowledge that industry self-regulation is working and give the process time to take root,” said Coalition for Healthcare Communication Executive Director John Kamp. “Even though industry needs to do more to fully engage Web stakeholders, early efforts are very promising. Voluntary, collaborative self-regulation is far superior to government regulation.”
The trade association letter stresses that voluntary codes of conduct, unlike government regulation or legislation, “can adapt in a timely manner to shifting technologies, business models, and consumer expectations.”
Indeed, in February, the Digital Advertising Alliance (DAA) and its members were praised by White House, Department of Commerce and Federal Trade Commission officials for their efforts, which include the DAA’s Self-regulatory Program for Online Behavioral Advertising and “Your Ad Choices” public education advertising campaign.
Voluntary programs, the industry groups contend, also can address privacy concerns “without interfering with innovation, which benefits consumers by delivering paychecks, savings, and exciting products and services.” These programs, they conclude, are “the ideal way to balance privacy and innovation.”
Meanwhile, Kamp implores industry members “to get on board with voluntary programs today to help prove industry’s commitment to consumer privacy, because legislation will come in the absence of robust industry participation.”
In addition to the Coalition, associations signing the letter include: American Advertising Federation, American Association of Advertising Agencies, American Business Media, Association of National Advertisers, Consumer Electronics Association, Direct Marketing Association, Financial Services Roundtable, Interactive Advertising Bureau, National Retail Federation, NetChoice, Online Publishers Association, Performance Marketing Association, Toy Industry Association, and U.S. Chamber of Commerce.
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. 23, 2012 – At a White House meeting held today to unveil the blueprint for the Obama Administration’s “Consumer Privacy Bill of Rights,” the Digital Advertising Alliance (DAA) and its members were praised by White House, Department of Commerce and Federal Trade Commission officials for their efforts during the past three years to protect consumers’ privacy online. These efforts include the DAA’s Self-regulatory Program for Online Behavioral Advertising and last month’s “Your Ad Choices” public education advertising campaign.
“While privacy remains one of the most challenging issues in the Internet age, the Coalition for Healthcare Communication, through its work with the American Association of Advertising Agencies, is proud to be part of the solution announced by the White House today to enable consumers to better exercise their privacy and marketing preferences,” said Coalition Executive Director John Kamp. “Much still remains to be done, including urging all Web publishers, agencies and clients to take full advantage of the DAA’s self-regulatory program in order to create a more robust and trustworthy Internet marketplace,” he added.
The DAA also announced today that it will immediately begin work to recognize browser-based choices with a set of tools by which consumers can express their preferences under the DAA principles.
“The Administration, Congress, and the FTC have been pushing the business community for several years to make sure consumers are aware of the information practices occuring online and providing choices to consumers regarding the collection and use of information about them,” said DAA General Counsel Stu Ingis. “The DAA is an embodiment of leading companies responding to this call.”
For more information on this groundbreaking news, see the press release from the 4A’s, released at noon today: http://www.aaaa.org/news/press/Pages/022312_daa_whitehouse.aspx
Feb. 3, 2012 – There are just 10 days left to comment on an FDA draft report that explores the best way to present risk and benefit information in prescription drug ads.
The draft report, “Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review,” which was made public at the end of 2011, attempts to provide insight regarding the value of quantitative data, how the presentation of the data influences patients’ and clinicians’ processing and understanding of risks and benefits, and whether a “Drug Facts” box on promotional labeling or print advertising would improve healthcare decisionmaking.
Three key literature review findings in the report – issued by RTI International on behalf of the FDA – are:
- Numeric presentation of risk/benefit information appears to have had a positive impact on several outcomes relative to non-numeric presentation of risk/benefit information.
- No specific, single format, structure or graphical approach emerged as consistently superior.
- Numeracy and health literacy are variables that deserve more empirical attention, because results may vary for different people depending on their numeracy and literacy levels.
RTI notes in the report that there are important gaps in the current literature, such as a predominant focus in the literature on risk information alone versus studies of both risk and benefit information. However, the report states that evidence suggests “that using relatively simple presentations of numeric and non-numeric information appears to be important to prevent overwhelming viewers, regardless of the specific approach employed.”
The agency is accepting both electronic and written comments referencing on the literature review report (referencing Docket No. 2011-N-0813) by Feb. 13. The Coalition for Healthcare Communication is seeking input from the community to inform its comments, and also encourages industry entities to comment to the agency directly. To share your perspectives with the Coalition, please contact Coalition Executive Director John Kamp at jkamp@cohealthcom.org.
Feb. 2, 2012 – More than four hours of testimony before the House Energy and Commerce Committee’s Subcommittee on Health — and members’ follow-up – nearly exhausted the issues related to the Prescription Drug User Fee Act V (PDUFA V) legislation yesterday, but just one question focused on drug marketing.
“It has taken hard work so far to keep direct-to-consumer [DTC] and other marketing on the back burner in PDUFA V,” said John Kamp, Executive Director of the Coalition for Healthcare Communication. “But I’m still worried. Consumer and other groups pressed FDA at several points last year in the FDA phase. I don’t think they are going to give up now, so we’re watching carefully and remain prepared for a challenge.”
During the Feb. 1 hearing, medical marketing was raised just briefly. “Do you actually have any resources for DTC advertising monitoring to ensure that consumers do have a balanced understanding of the drugs and the risks advertised to them and the accuracy of those?” Rep. Jan Schakowsky (D-Ill.) asked Commissioner of Food and Drugs Margaret Hamburg, M.D. “Where are we with monitoring these DTC drug ads?” she queried.
“We do have a group that is charged with working on the oversight of DTC advertising and there is a process that involves the screening of the DTC advertisements,” Hamburg said, adding that “we don’t have fees associated with that.” Hamburg explained that although advertising was considered in previous PDUFA negotiations, “it is not part of PDUFA V.”
Hamburg said she gathered “that in the last PDUFA negotiation this had been identified as a possible area of focus, but actually including it was moved away from for a number of reasons that I think may have included the willingness to … include budget authority.”
“Hamburg’s response is right and appropriate,” Kamp said. “May it be the last word. However, we’re not betting the farm,” he added.
Indeed, although the exchange between Schakowsky and Hamburg was the only mention of drug advertising during this comprehensive hearing, it is unlikely to be the last, especially considering Schakowsky’s ending remark: “Given the prevalence of those ads on television, I would think that should be a major focus and I hope we can work together to make that happen,” she concluded.
Recent efforts by other entities to push for drug marketing restrictions or greater regulation of DTC ads as a part of PDUFA V are worth noting. An Aug. 31, 2011, letter from the Pharmaceutical Care Management Association (PCMA) to the Joint Select Committee on Deficit Reduction called suppressing the use of branded drugs and eliminating the tax deduction for DTC advertising “debt-reducing solutions” that it claims, combined with other prescription drug measures, could save the federal government $100 billion over 10 years.
In highlighting the PCMA recommendation to ban the DTC advertising tax deduction, the letter states that “while the First Amendment allows for such advertising, it does not require tax payers to subsidize promoting the most expensive drug treatments.”
Further, a last-minute plea from a coalition of consumer groups to Department of Health & Human Services Secretary Kathleen Sebelius asked that more marketing rules – including expanded capacity for monitoring of DTC advertising – be added to PDUFA V language.
In tandem, these proposals forward the view that further discussion of marketing in the context of PDUFA reauthorization legislation is likely to rear its head again.
“Once groups like PCMA and Consumers Union take a position, they seldom give up easily,” said Kamp. “It would be naïve to think that our fight is over.”
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