1

CER, FDA, and the Free Speech Challenge

Tevi D. Troy, PhD

Senior Fellow, Hudson Institute

Former Deputy Secretary, U.S. Department of Health and Human Services

2

Understanding the FDA’s View on Free Speech

• FDA has seemingly different views on Free Speech than most Americans, or even the Supreme Court

• "[I]n certain areas of extensive Federal regulation . . . The Government may regulate communications of the regulated parties without offending the 1st Amendment." (62 FR 64077; 1997)

• "Contrary to the view of the comments, the 1st Amendment does not guarantee the right to employ every conceivable method of communication at all times and in all places. Indeed, Freedom of Speech does not include the freedom to violate the labeling provisions of the Federal Food, Drug, and Cosmetic Act. . . [T]hese regulations are valid under the limited scrutiny that has been afforded restrictions on speech under extensive regulatory schemes involving areas of economic activity (59 FR 395, 421; Jan. 4, 1994)

• FDA views on physician-company interactions, ads, social media, and the dissemination of peer-reviewed studies and journal articles may tell us something about how they could handle CER

3

Restrictions on Marketing FDA guidance docs place limits on the interactions between

pharmaceutical companies and physicians.

The exchange of scientific information is allowed in the following circumstances:

• responses to unsolicited requests from physicians involving unapproved uses of legally marketed products;

• continuing medical education (CME) programs, providing the program is not promotional and separate from the influence of the company; and

• studies in peer-reviewed scientific and medical journals that are both well controlled and considered scientifically sound.

-- American Academy of Orthopaedic Surgeons

4

Restrictions on Advertising

• The FDA recently began its “Bad Ad” program, to encourage physicians to report illegal or misleading advertisements or interactions with drug companies

• Pfizer received a letter for a technical problem in one area on their website

• Prescription drug advertising must:

• Be accurate

• Balance the risk and benefit information

• Be consistent with the prescribing information approved by FDA

• Only include information that is supported by strong evidence from clinical studies

--FDA/DDMAC FAQS

5

Restrictions on Advertising

Common violations include:

• Omitting or downplaying of risk;

• Overstating effectiveness;

• Making misleading drug comparisons.

--FDA/DDMAC FAQS

•Note: FDA released guidance in December regarding promoting off-label, or unapproved, uses.

•The new guidance gave specific ways in which companies can respond to public unsolicited requests for unsolicited information about off-label use.

6

Lack of Guidance on Social Media • Social Media now accounts for nearly five percent of drug companies’

advertising budget, according to Bill Trombetta, a professor of pharmaceutical marketing at St. Joseph’s University in Philadelphia.

• In an address to DIA’s annual marketing meeting, Tom Abrams said that, for the moment, HHS does not want to issue guidance that will be “quickly outdated,” thus, making it difficult to issue platform-specific guidelines for sites that may soon fade.

• However, the new guidance will address “some specific matters,” but will not include any “new regulations or new standards.”

• Abrams responded to questions about Novartis’ Facebook widget: “These Warning Letters cite existing rules and do not make new policy.”

7

FDA: Social Media for Me But Not for Thee

In 2010, the FDA released its Strategic Priorities 2011-2015. It provided some insight into the FDA’s thinking going forward:

“Social media tools can help meet some of FDA’s communication challenge” -- page 13

This is the only reference to social media in the 50-page document.

“[FDA must] oversee drug promotion and marketing to ensure that marketed drug labeling and advertising are truthful and not

misleading” -- page 25, Table III

Summary of Long-Term Objectives for Human Drugs

Such preliminary guidance indicates the FDA will continue to monitor all avenues of communication with patients.

8

Comparative Effectiveness Research

• President Obama laid out the premise of CER in a 2009 speech, saying: "If there's a blue pill and a red pill, and the blue pill is half the price of the red pill and works just as well, why not pay half price for the thing that's going to make you well?"

• The American Recovery and Reinvestment Act of 2009 allocated $1.1 billion for comparative effectiveness research (CER), to be divided among the National Institute of Health, the Agency for Healthcare Research and Quality, and the Office of the Secretary.

• Affordable Care Act provided $4.5 billion for CER for 2010-2019 (16% goes to AHRQ for translation and dissemination efforts)

9

Comparative Effectiveness Research

Recent Developments

•Patient Centered Outcomes Research Institute (PCORI – a non-governmental agency) released its draft CER research program agenda in late January.

•Laid out five priorities and where it planned to dedicate funding, but did not propose examination of specific conditions or treatments.

•Lack of specificity widely criticized, may stem from not wanting to alienate stakeholders.

•Politico’s Brett Norman: PCORI announcement “may scatter the agency’s focus so widely that it could undercut the impact supporters hope to see.”

10

Putting Them Together: FDA and CER

• CER program could present a public health challenge when married with FDA approaches to free speech

• The CER program will provide ammunition to critics of pharmaceutical and medical-device companies

• FDA rules and policies will challenge the ability of pharmaceutical and medical device companies to respond to these critiques

11

Unfair Restrictions

• According to FDA guidelines, pharmaceutical companies can generally only talk about studies comparatively if there have been two robust head-to-head trials

• If drug companies compare indications or safety data without these two trials, they may well receive a letter from the FDA

• All other organizations – the payer, the government, FDA critics– can compare without two trials

12

Effects of Asymmetry

• These restrictions could impose a significant handicap on pharmaceutical and medical-device companies by creating an asymmetry in the ability to disseminate information and respond to claims

• This asymmetry not only makes it difficult for companies to operate, but could also prevent important information from reaching patients, payers, and doctors

13

Office of Prescription Drug Promotion

• Lack of written guidance from the Office of Prescription Drug

Promotion (OPDP) and other offices leads the regulated community to seek guidance from “podium policy,” even though current regulation says this is not law.

• In many cases, there’s no transparent process for making law, and no mechanism available for pushing back for fear of prosecution or exclusion.

14

Letters Effectively Have the Force of Law

• Companies have limited options for challenging letters • The availability of judicial review is highly uncertain • Companies are understandably wary of challenging FDA

because of the severity of the possible penalties

15

Oddity: The FDA vs. the NIH

Example…

•The website of the National Institute of Health (NIH) recently commented on an anti-depressant study, observing it was unlikely for any future similar studies to be run – it was too expensive, and this was as good as it gets when it comes to studies

•Lilly cited the study, and then received a letter from the FDA chastising it for making claims based on the study

16

Summary: FDA and CER Marriage May Create a Significant Public Health Challenge

• FDA has seemingly different views on Free Speech -- see themselves as public health officials more than regulators

• These views in other areas such as social media and the distribution of peer-reviewed literature will likely help shape the FDA’s approach to the emerging world of CER

• Klasmeier/Gottlieb: “[T]he FDA could be put into conflict with the new agency, and the private sector will be held to a much higher standard than the government when it comes to the degree of reliability that evidence must have to support decisions based on its findings.”

• This situation would not be good for anyone, let alone the public health

17

Conclusion: Need for Clear Rules

• Proposed solution: FDA should issue clear guidelines leveling the playing field for debate over the new research

• Clear guidelines will help create an open dialogue regarding new research emerging from CER efforts

• Level playing field is the only way to get the fullest possible dialogue regarding the strengths and weaknesses of various therapies

• Concern is that understandable yet typical FDA caution will prevent timely creation of suggested guidelines

18

CER, FDA, and the Free Speech Challenge

Tevi D. Troy, PhD

Senior Fellow, Hudson Institute

Former Deputy Secretary, U.S. Department of Health and Human Services