FDALegislativeWatch

Marketing Oversight By States Creates Multiple Compliance Standards For Firms

As more and more states pass laws that require pharmaceutical companies to disclose payments to health care practitioners, there needs to be a single definition of which data must be reported, according to John Patrick Oroho, executive vice president of Porzio Pharmaceutical Services.

"It's difficult to track the information in the first place, but it's a lot more difficult when you have different definitions across the country," Oroho said in an interview.

The marketing disclosure bills introduced in nine states during 2008 contain varying reporting thresholds and exemptions, Oroho pointed out during a recent Center for Business Intelligence conference. PPS provides consulting services on federal and state regulations governing pharmaceutical marketing and sales practices.

PhRMA’s Marketing Code Touts Sarbanes/Oxley-esque Compliance Mechanism

The Pharmaceutical Research and Manufacturers of America's revised marketing code will use an executive certification standard similar to Sarbanes-Oxley to assure compliance.

The new PhRMA rules were unveiled July 10 and take effect in January. The ¹new code on company interactions with health care professionals is considerably stronger than the association's ²2002 code.

A notable feature is the use of a compliance mechanism modeled on the Sarbanes-Oxley securities law, which requires top executives of publicly traded companies to personally attest that company financial records are accurate. The Sarbanes-Oxley requirement has drawn some complaints from corporations that it is too burdensome. PhRMA's adoption of a similar approach signals the strength of the association's effort to eliminate perceptions that companies' dealings with doctors might be inappropriate.

Pfizer CME Restrictions: No Support For Education Firms, Caps Everywhere Else

In response to the medical community's call for continuing medical education to receive financing from a variety of sources, Pfizer is limiting the percentage of funding it will provide for any one CME program.

Effective immediately, the firm also is ending direct financial support for CME provided by medical education and communication companies, Pfizer announced July 2, although it will honor existing commitments.

CME at academic medical centers and teaching hospitals or sponsored by associations, medical societies and community hospitals, including for-profit hospitals, will continue to be funded.

Drug Firms To Adopt AMA Guidelines On Physicians In DTC Ads

Four leading drug companies have pledged to follow American Medical Association guidelines on portraying physicians in direct-to-consumer ads, which may lead to broader adoption of the principles by other firms.

Under the guidelines, an appearance by a real physician must be accompanied by the statement that the physician has been compensated and ads also must disclose when an actor is used to portray a doctor.

Concerns with the portrayal of doctors in DTC ads were heightened recently by Pfizer's use of artificial heart pioneer Robert Jarvik in TV spots for Lipitor ¹("The Pink Sheet," March 3, 2008, p. 10).

AMA Delegates To Debate Gift Reporting; Sunshine Bill Still Has Ray Of Hope

The American Medical Association will evaluate mandatory disclosure of financial relationships between physicians and the pharmaceutical industry during the group's June 14-18 House of Delegates meeting in Chicago.

The House of Delegates establishes AMA policy positions that guide lobbying on legislative and regulatory matters.

The California delegation is proposing a resolution that calls for annual reporting by drug and medical device companies of all payments to physicians with a value of more than $100. Product samples for patients and meals provided in conjunction with educational meetings would be exempted. The resolution is silent on whether the reporting should be to a state or federal government agency.

Sunshine Bill Gains Momentum From PhRMA But Time May Be Running Short

With an endorsement by the Pharmaceutical Research and Manufacturers Association and three drug companies, momentum is building for Senate legislation to set up a federal reporting program for drug and device companies to disclose their gifts to physicians.

The question now is whether it is too late to secure passage in the current Congress or if the momentum is enough to propel the proposal onto a vehicle such as the upcoming Medicare physician payment legislation.

Sens. Herb Kohl, D-Wis., and Chuck Grassley, R-Iowa, introduced the Physician Payments Sunshine Act, S. 2029, last year to mandate the listing of industry gifts in a national online, publicly-accessible database. They have since made revisions, including a pre-emption of state reporting laws, to attract industry support (¹"The Pink Sheet," May 19, 2008, p. 3).

Grassley, Kohl Retool Physician Gift Reporting Bill To Defuse Opposition

Sens. Chuck Grassley, R-Iowa, and Herb Kohl, D-Wis., plan to add a state pre-emption provision to their Physician Payments Sunshine Act as they try to attach it to a Medicare bill being written by the Finance Committee.

The sunshine bill, S. 2029, would require drug and device companies to disclose their financial relationships with doctors in a national, publicly available registry operated by HHS (¹"The Pink Sheet," Sept. 24, 2007, p. 8).

In the new version of the bill, the senators would not only establish the national reporting program, but also direct that it override various state requirements, giving industry a single reporting standard (²"The Pink Sheet," July 23, 2007, p. 17).

FDA Preemption Deadlocks Supreme Court; Congress Pushes to Resolve Issue

Citing a crisis within FDA, members of Congress are demanding that the agency withdraw its proposed rule to limit when drug and device manufacturers can revise their product labeling without prior FDA approval.

In a March 3 letter to FDA Commissioner Andrew von Eschenbach, 17 members of the House Oversight and Investigations Subcommittee contend that the agency is unable to review warning label changes fast enough. They say FDA should continue to allow companies to amend their product labels to warn consumers of potential risks "at the earliest possible moment."

Assault on Drug Marketing Tactics Becomes Drug Specific On Capitol Hill

This article is reprinted from "The Pink Sheet" - January 28, 2008

Pharmaceutical firms avoided a moratorium on direct-to-consumer television ads in the FDA Amendments Act, but that victory seems of little comfort now as Congress undertakes a wide-ranging probe of industry marketing practices.

A flurry of letters from House Energy and Commerce Committee leaders last week continued to question the motives of Merck and Schering-Plough in delaying the release of data from the ENHANCE trial for Vytorin.

DTC User Fee Program Suspended By Congress; FDA Gets More Review Funds

This article is reprinted from "The Pink Sheet" – January 7, 2008

Congress has increased the amount of federal money available to fund FDA review of direct-to-consumer television ads rather than appropriate user fees negotiated by FDA and industry to speed up the ad review process.