Originally Published MDDI March 2002

WASHINGTON WRAP-UP

HHS secretaries have tried clamping down on their public affairs offices in the past with minimal harm, but the stakes are far higher in the age of the Internet.

James G. Dickinson

First Wearable Defibrillator | Export Reporting Burdens Eased

The free flow of information from government agencies has been a hazard of the job for legions of cabinet secretaries. Jimmy Carter's secretary of health and human services, Joe Califano, was famous in government circles for saying, "Just don't surprise me." In other words, he didn't want to read bad news from FDA in the Washington Post over his morning coffee.

FDA is one of more than 50 HHS agencies with their own public affairs offices. This decentralization has assured many a spilt cup of coffee for HHS secretaries, who have tried a variety of mostly ineffectual ways to control these offices. In January, Bush secretary Tommy Thompson decided to succeed where his predecessors had failed—he launched a reorganization of all the legislative and public affairs offices in HHS health agencies, centralizing their functions in his office.This massive action provoked fears of a slowdown in the flow of FDA information to the public and Congress, as well as concern that it would provide rich new opportunities for political spin to be placed on that information.Until now, FDA's public affairs office has been a spigot of valuable daily information for many, not just the news media. One increasingly important activity is stocking the FDA Web site with objective, unbiased information and agency documents. Medical device companies, in particular, often rely on informal news releases known as FDA talk papers, which address important product approvals or public health and safety alerts. Talk papers are themselves a legacy of a long-ago HHS secretarial attempt to control its agencies' freedom of speech. After an edict that only the HHS secretary's public affairs office could issue press releases, FDA invented talk papers, partly to bypass this stricture.Officially, talk papers cover issues of the day for internal FDA consumption, to ensure that the agency's far-flung offices give consistent answers to questions. In practice, however, talk papers can do the same job as a press release on noncontentious issues, and they avoid clearance delays in the upper reaches of HHS.FDA press officers have other alternatives to press releases as well. Frequently, they will alert media contacts to newsworthy advisory committee meetings on health product issues, sometimes to the unforeseen embarrassment of the sponsoring company.Never mind the fact that 99.9% of the materials issued from FDA's public affairs office have objective, scientific, public health–oriented purposes. All are now likely to be slowed down, or even side-tracked, by high-level layers of policy review and approval in Thompson's office.According to the Washington Post, there may be more to Thompson's reorganization than the new management and efficiency structure he cites. In a January report on the change, the newspaper noted that during the anthrax crisis, Thompson had been criticized for information he managed that conflicted with that released by experts at the Centers for Disease Control and Prevention. Out of that embarrassment, informed sources say, Thompson decided he needed tighter control on information flowing from his agencies.Such secretarial determinations have a long history. One former FDAer remembers that in the late 1980s most information flowing from FDA had to pass different levels of review not only at the agency, but also at HHS. And because of differing opinions and personalities, these reviews often completely altered the information or messages being released. Another initiative under the Reagan administration sought to do away with any federal publication that was not required by law. At the time, this pitted FDA against the administration in a fight to save its treasured FDA Consumer magazine.FDA's release of information about medical products can be a two-edged sword, enhancing a product's marketing efforts when positive and doing harm when negative. But delays in getting FDA information—good or bad—can fuel paranoia in the mass media, and even give the appearance of a cover-up. Whether the Thompson restrictions will turn out to be a blessing or a curse—if they succeed at all—remains to be seen.
First Wearable DefibrillatorFDA has approved a Lifecore wearable cardioverter-defibrillator, the first cardiac defibrillator that can be worn outside the body instead of being implanted inside a person's chest. According to an agency news release, the vestlike device is worn under clothing. Its programmable system senses heart function, automatically delivering an electric shock when needed to restore normal heart rhythm in patients at risk of dying from sudden cardiac arrest. Traditional cardioverter-defibrillators have had to be surgically implanted in a patient's chest, FDA said.According to the news release, the device consists of an electrode belt assembly that is worn around the chest, touching the skin, connected to a monitor with an alarm worn in a holster around the waist. The device is worn continuously 24 hours a day, except when the wearer is bathing or showering. It can be plugged into a modem once a week to send data to the patient's doctor for review.FDA said its approval was based on clinical studies of safety and effectiveness involving 289 heart patients at 16 medical centers who were fitted with the defibrillator vest. All were either waiting for a heart transplant or had recently had a heart attack or coronary bypass operation, and wore the device for an average of 20 hours a day for approximately three months. The agency said the wearable defibrillator was 71% successful in treating sudden cardiac arrest episodes, compared with 25% for patients calling 911. The rate of unnecessary (false) shocks from the wearable device was also lower for patients wearing the vest than for those with implantable defibrillators, the agency said.
Export Reporting Burdens EasedFDA has reduced the export reporting and notification burdens it outlined in April 1999 in a proposed rule. The final rule, Exports: Notification and Recordkeeping Requirements, published in January, no longer contains its proposal to require letters from officials of importing countries to demonstrate that U.S.-exported products do not conflict with the laws of their countries.Instead, FDA says that it will allow a notarized certification from a responsible company official in the United States attesting that a product is not in conflict with the importing country's laws. The final rule implements a 1996 law called the FDA Export Reform and Enhancement Act, which broadened the criteria for allowing the export of unapproved drugs and devices.The final rule also withdraws a proposal requiring companies to provide notifications of export for products that are shipped in anticipation of foreign marketing authorization. In addition, FDA says that it is preparing another proposed rule to address drugs and biologics that are exported for investigational use. That proposed rule is intended to streamline the requirements for nvestigational-use-only products and will address 21 CFR 312, which outlines requirements for exporting with or without an IND.To review the final rule, visit http://www.fda.gov/OHRMS/DOCKETS/98fr/98n-0583_nfr0001.pdf.Copyright ©2002 Medical Device & Diagnostic Industry