Originally published March 1996
In a major policy move designed to defuse the ticking First Amendment time bomb that threatens its control of product marketing, FDA in December unveiled two draft guidances that offer relief to product marketers. The new guidances would allow device, drug, and biologics companies to disseminate to prescribers journal articles that describe efficacy studies FDA relied on in approving a product even if the articles also mention unapproved uses, and to disseminate textbooks that do the same--all subject to certain restrictions, of course. FDA posted only a 30-day public comment period, instead of the usual 60 or more days, apparently in hopes of being able to announce final policies that could influence both a pending Washington Legal Foundation First Amendment case against current regulatory policy and possible FDA reform legislation on Capitol Hill.
Another factor driving FDA's shortened time frame was industry's known proclivity for jumping the gun. An agency spokesman said the old policy would continue to be routinely enforced until it was replaced.
The first draft guidance allows firms to disseminate articles from peer-reviewed journals that discuss the effectiveness trials relied on by FDA to approve a product, provided, first, that any departures from final, approved labeling are prominently stated "with specificity" on the face of the article, and, second, that reprints of the article "disclose all material facts" and are not "false or misleading."
The second draft guidance allows the dissemination of independently written, edited, and published textbooks that are generally available other than through the disseminating device firm, and that don't focus primarily on its products or on their unapproved uses. In the case of textbooks, the draft says, "specific product information (other than the approved package insert) should not be physically appended to the reference text."
Firm-initiated device recalls that are conducted to modify a product will soon receive faster FDA reviews, according to a November 21, 1995, guidance document. In the past, CDRH's Office of Compliance (OC) relied on its sister Office of Science and Technology to assess the recalling company's modification to see if it warranted a new premarket notification. If it did, the Office of Device Evaluation (ODE) would be called in to review and issue a clearance before the firm could put the change into production. "This process involved redundant reviews and potentially conflicting assessments of the same modification, and could unnecessarily delay corrections of defective devices," says CDRH's new "Guidance on Recall and Premarket Notification Review Procedures during Firm-Initiated Recalls of Legally Marketed Devices."
To speed things up, an OC case officer will triage the firm's "recall strategy" during the initial recall action to determine whether the modification alters the device or restores it to original specifications. In the latter case, the case officer will not require a 510(k) and will "process the recall accordingly." However, if the device is altered, ODE will then take over to assess whether a 510(k) is needed, concentrating mainly on whether the alteration could affect safety or effectiveness and thus require a 510(k) submission and a halt to the firm's production until clearance is obtained. Those modifications not affecting safety or effectiveness will be processed accordingly via OC's case officer.
Because FDA commissioner Kessler has apparently failed to convince Congress that his agency is not an intimidating bully, House Commerce oversight and investigations chairman Congressman Joe Barton (RTX) is planning to legislate the creation of an independent body to police FDA actions. Barton said he wants FDA's regulated industries to have "an appeals process that actually works" for questioning the agency. Last December 5, for the second time in a month, Barton's committee in public session sought proof from Kessler that the agency does not harass or retaliate against firms that challenge FDA's policies, processes, and actions. Kessler repeatedly denied clear-cut wrongdoing in how his staff handled retaliation charges.
James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry.