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Recent Second Opinion:

Post-Election Predictions for Obamacare
November 11, 2010

Improving the FDA's REMS Program
August 05, 2010

Are Foreign Clinical Drug Trials Safe?
July 08, 2010

FDA's Bad Ad Program
June 03, 2010

Obesity and Public Health
May 05, 2010

The Route to Reconciliation
March 05, 2010

Conflict of Interest
January 28, 2010

Analyzing the Healthcare Bills
November 18, 2009

President Obama's Plan for Reform
August 24, 2009

The Healthcare Reform Debate
July 23, 2009

Priorities for the New FDA Commissioner
December 19, 2008

PhRMA's New Marketing Code
August 28, 2008

Personal Genetics Testing
July 29, 2008

Where health care policy experts have their say
June 13, 2008

Sources of Medical Research Funding
April 24, 2008

Off-Labeling Marketing
March 17, 2008


Second Opinion:
Where health care policy experts have their say

June 3, 2010:
FDA's Bad Ad Program

Recently, the FDA announced its new "Bad Ad" program, where physicians could anonymously report ads and sales pitches that potentially violate FDA regulations. For this edition of our Second Opinion forum, we've asked policy experts if they think the FDA's new "Bad Ads" program will increase compliance with FDA marketing regulations and improve patient care, or will it "muddy the water" by allowing anti-pharma groups to deluge the agency with manufactured complaints.

This edition of our expert panel includes:

  • Benjamin Zycher, senior fellow at the Pacific Research Institute
  • Peter J. Pitts, President of the Center for Medicine in the Public Interest and former FDA Associate Commissioner
  • Dr. Elizabeth M. Whelan, President of the American Council on Science and Health
  • Sean Khozin, MD, MPH, a practicing physician in New York City and the co-founder of Hello Health

By Benjamin Zycher

People are idiots; they are incapable of making rational decisions in consultation with their doctors. Informants have no agendas of their own. Physicians are like bacteria: Their decisions and behavior depend on conditions in whatever petri dish they happen to find themselves. Thus are they manipulated easily by Madison Avenue smoothies hiding subliminal messages in advertisements, or by pharmaceutical representatives offering mouse pads and other such priceless tshatshkes otherwise impossible to find, and for which women gladly would offer themselves in times of war or peace. Federal bureaucracies, on the other hand, are not fooled, and know what goes through physicians' minds—every one of them—when confronted with "misleading" promotions. And that very same federal bureaucracy, led by powerful political incentives to ignore the needless suffering and mortality caused by the absurd costs and time delays inherent in its formal approval process for pharmaceuticals, is "understaffed," with enforcement budgets inadequate for its mandated tasks, and thus finds it necessary to invite the participation of the citizenry in the long twilight struggle with "misleading" direct-to-consumer drug advertising.

If you believe those things, then the Food and Drug Administration's new "Bad Ad" program is just the ticket. Too few bureaucrats? No problem: The doctors will snitch on the pharmaceutical producers' misleading pitches.  But, of course, it is not the doctor reporting such perfidy who is misled, by definition; it is his quack competitor down the hall. And misleading promotions are not quite the problem either; it is instead violation of FDA rules, about which the doctors surely are not experts. But fear not: The FDA "plans on educating doctors and medical professionals on how to recognize a misleading ad." Well, all right then!

Either physicians in the aggregate will refuse to waste their time on such foolishness, in which case the understaffed FDA's "Bad Ad" program will collapse even if we accept its absurd assumptions; or they will file such reports in the hundreds of thousands or millions, in which case the understaffed FDA's program will collapse a fortiori. Thus will the FDA be able to use this forthcoming failure as a rationale for a bigger budget.  Just as the private sector in general and the drug producers in particular must accept risk as a normal part of the economic environment, the Beltway offers certainty: Its ideas are dangerously short-sighted, it views the citizenry as children, its programs will fail, and as a result its budgets will grow. Is this a great country or what?

Benjamin Zycher is a senior fellow at the Pacific Research Institute, the President of Benjamin Zycher Economics Associates, and an adjunct Professor of Economics and Business at the Martin V. Smith School of Business and Economics, California State University, Channel Islands. In addition, he is a member of the advisory board of the quarterly journal Regulation, of the advisory council of USA for Innovation, and the advisory council of Consumer Alert.

* * *

By Peter J. Pitts

FDA's "Bad Ad Program" is a bad idea.  It’s lettre de cachet approach—actively soliciting anonymous admonishments from "deputized" physicians is a poorly thought out ad hoc approach that will not make bad ads better but will, alas, have the unintended consequences of putting the agency further into hock. An already overworked and understaffed DDMAC simply does not have the bandwidth to actively pursue "leads" provided by physicians who are unversed in what defines "compliance." Not liking an ad doesn't make it "bad"—and since roughly a third of physicians regularly say they don’t like DTC advertising, it’s not unrealistic to predict that the Star Chamber e-mails sent to the FDA will be interesting from a social science perspective—but almost entirely useless for enforcement purposes.  Further, since neither name nor medical license is required it is, unfortunately, entirely predictable that "Bad Ads" will certainly be used by the anti-DTC crowd to "stuff the ballot box" in pursuit their anti public health, anti-pharma jihad. When it comes to transparency—the FDA is talking the talk—but not walking the walk.

Peter Pitts is President and co-founder of the Center for Medicine in the Public Interest and Partner/Director Global Healthcare, Porter Novelli. Prior to founding CMPI, Pitts was a Senior Fellow for healthcare studies at the Pacific Research Institute. From 2002-2004 Peter was FDA’s Associate Commissioner for External Relations, serving as senior communications and policy adviser to the Commissioner.

* * *

Bad Ads, Badder FDA

By Dr. Elizabeth M. Whelan

No one wants misleading pharmaceutical advertising, but the Food and Drug Administration's plan to deputize doctors to police drug companies is a misguided effort.

Most physicians and health care workers simply don't have the hard data necessary to judge whether an ad overstates a drug's efficacy or plays down its risks. The hundreds of needless reports will distract the FDA from its core mission.

And the program isn't even limited to medical professionals; anyone will be allowed to file anonymous complaints. It's easy to imagine competitors or ideological activists trying to sabotage a new drug.

Ultimately, encouraging colleagues to report on colleagues is unprofessional and can only foster adversarial relationships between physicians and pharmaceutical companies.

Instead, why doesn't the FDA try training a small group of doctors and paying them a modest honorarium to monitor ads? This would give the agency a manageable amount of feedback, instead of the chaos of unlimited submissions.

Dr. Elizabeth M. Whelan is President of the American Council on Science and Health (ACSH) and a member of its Board of Trustees. She founded ACSH in 1978. A graduate of Connecticut College, she has a Masters in Public Health from the Yale School of Medicine, a Master of Science from the Harvard School of Public Health , and a Doctor of Science from the Harvard School of Public Health.

* * *

FDA's Bad Ad Program

By Sean Khozin

Physicians and patients need scientifically accurate and unbiased information about drug therapies and responsible promotional efforts by the pharmaceutical industry can be a great source of such information. In order for the Bad Ad initiative to have a positive impact, the FDA would need to maintain a threshold for the program in a way that it captures misleading advertisements while preventing action against truthful promotional programs. This requires a proactive approach to educating physicians and the industry on what constitutes a "bad ad" and a mechanism for efficiently investigating the incoming claims. Ensuring the quality and accuracy of pharmaceutical promotional programs is an endeavor involving multiple stakeholders. With the Bad Ad program, the FDA has an opportunity to promote a culture of  responsible advertising if the stakeholders are given a chance to adopt a tone of collaboration and discouraged from engaging in antagonistic behavior.

Sean Khozin is a practicing physician in New York City and the co-founder of Hello Health, a web-based electronic medical record system and communication platform that enables doctors and patients to connect online via email, instant messaging, and video chat. This week, Khozin discusses over-the-counter genomics testing and the integration of technology into the direct care model.

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