Originally published August 1996
James G. Dickinson
Although the Federal Trade Commission (FTC) was assigned by Congress to be the lead agency in regulating the marketing of medical devices, FDA's expansion into this area has proceeded swiftly, and without apparent FTC protest, since agency commissioner David A. Kessler came aboard five years ago.
Until Kessler's arrival, FDA's Center for Devices and Radiological Health (CDRH) had no office dedicated to device marketing practices. In setting one up, Kessler drew from the expertise long established in the agency's Center for Drug Evaluation and Research (CDER)--specifically, its Division of Drug Marketing, Advertising, and Communications (DDMAC). The result of Kessler's efforts, the Promotion and Advertising Policy Staff (PAPS) of CDRH's Office of Compliance, is now firmly established and operating in much the same way as DDMAC--but more controversially.
One reason for the greater controversy is the symbolism of this development. Not only can the setting up of PAPS be interpreted as an encroachment of a more stringent agency on the laxer FTC's turf, but it also magnifies the perception of the "drug-izing" of medical device regulation.
Although there's little in writing to substantiate their argument, critics of FDA's expansion contend that in the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act), Congress intended the agency's role in the regulation of device marketing to be small. The amendments therefore limited FDA's activities to "restricted" devices (which Congress did not define), and then only to the actual advertising of such devices, not their promotional labeling. Congress, these critics say, intended FTC to have exclusive jurisdiction over the marketing of most devices. Since 1976, FDA has exercised its authority over restricted-device marketing only once, to regulate the advertising of hearing aids.
But nature, it is said, abhors a vacuum. And so, apparently, does FDA. With no definition of restricted devices in the FD&C Act, and with Kessler deciding to harmonize his agency's approach to regulation across product lines in order to achieve the greatest possible uniformity, it followed that the weaker and less-defined area (devices) would soon be invaded and filled by the operating policies of the stronger and more explicitly defined area (drugs).
Why FDA did not use the FD&C Act's restricted-device provision as the basis for formally embracing more devices than hearing aids is anybody's guess. Perhaps it was just easier to restrict certain devices informally, through the terms of their approval letters--which is what FDA has been doing for devices that enter the market through the premarket approval (PMA) process. In reality, though, it is probable that FDA did not deliberately set out to acquire restricted-device classifications in this indirect manner during the time between passage of the 1976 amendments and the accession of Kessler, but rather developed the strategy only after he came aboard.
This retroactive harvesting of informally restricted PMA devices did not give FDA a large slice of FTC's turf, however. By far the overwhelming majority of new devices enter the market through the so-called 510(k) process, under which their manufacturers merely have to declare them "substantially equivalent" to predicate devices that were on the market before May 28, 1976.
In the case of PMA devices, FDA's tactic has given it an inventory of hundreds of devices that have been informally restricted through their approval letters. With nothing in the FD&C Act to contradict this approach, nobody in industry has yet sought a reversal in federal court.
In this respect, the medical device industry appears to have much in common with the drug industry, which has been reluctant to sue FDA over such regulatory adventures as appear to infringe on companies' First Amendment rights. Both industries, when encroached on by FDA, shrink from mounting a frontal legal challenge, reasoning that the agency that guards the gateway to their products' markets is not to be irritated unless a company's livelihood depends on it.
Kessler's harmonizing of FDA strategies with respect to drug and device marketing practices was reinforced by the posting of two highly skilled drug advertising experts, Arthur Yellin and Kenneth Feather, from CDER's DDMAC to CDRH's fledgling PAPS. Each served successive short-term assignments, Yellin first, then Feather.
DDMAC and PAPS now operate similarly as a result of this cross-pollination, but Feather observes that there are significant differences caused by the different statutory authorities. Since FDA doesn't have the same statutory authority to preclear new-device launch materials as it has to preclear such materials for new drugs, PAPS has no role in market launches. And, Feather notes, it does not issue as many advisories to marketers as DDMAC does. But it does listen to the same snitching among marketplace competitors as DDMAC does, and it monitors journal advertising as well as professional and trade presentations with the help of FDA field offices around the country.
PAPS director Byron Tart says that his staff, like DDMAC's, regulates "intended use." This means that if a device manufacturer uses an advertisement to change a product's intended use under 21 CFR 801.4 ("Special Requirements for Specific Devices"), then "we don't go after the advertisement itself, but we will comment on the fact that the intended use has been changed and that the manufacturer/ distributor may have misbranded or adulterated the device as a result."
This approach apparently gives PAPS a way of broadening its reach beyond PMA devices. "The intended use of a device," Tart explains, "can be changed by a manufacturer through advertising, statements that are made, including oral statements, and by whom they sell it to. So if a manufacturer changes the intended use, we would go after it because the labeling doesn't cover that intended use and neither does the 510(k) or the PMA application."
Another similarity between PAPS and DDMAC is that both employ letters to industry that contain nonpublic enforcement information. DDMAC's use of such letters is of longer standing and is more aggressive (and controversial) than PAPS's, often bypassing the use of conventional warning letters, which are public and therefore provide useful instruction on specific regulatory actions to nonparticipants.
Recently, DDMAC decided that its untitled letters may be accessed under the Freedom of Information Act (FOIA), thus releasing to requesters much valuable insight into practical interpretations of agency marketing policy. Then, in May, PAPS also OK'd access to its untitled letters under FOIA, releasing a batch of 22 to this writer.
These letters, like those of DDMAC, show a consistent pattern of FDA concern about off-label uses. For example, a February 5, 1996, letter to Fukuda Denshi America Corp. (Redmond, WA) complained that two information manuals not necessarily authored by the firm but distributed by it contained statements promoting the UF-4500 ultrasound scanner for intended uses not covered by the product's 510(k) application. PAPS consumer safety officer Steven Budabin wrote:
We also note that Fukuda Denshi has distributed promotional materials and has funded seminars and symposia which promote the UF-4500 for off-label uses. Although the agency does not regulate scientific and educational activities, it does regulate promotional activities by manufacturers.
Therefore, manufacturers may not provide equipment or devices for hands-on training purposes either directly or indirectly, to another distributor or supplier with knowledge that those devices will be used in a manner which promotes an off-label use.
Similarly, a manufacturer may not promote a device by distributing literature, publications, brochures, pamphlets, or other written materials which discuss the unapproved use of a device. Fukuda Denshi may, however, distribute reprints of journal articles in response to unsolicited requests from health-care practitioners.
Budabin's letter also objected to the company's use of its initials, FDA, throughout its literature, "since those initials may easily be confused with those of the Food and Drug Administration. You should be aware that reference to FDA in advertisements or other promotional materials for medical devices is prohibited by the [FD&C] Act and represents misbranding under section 502(a)."
In the past, in both DDMAC and PAPS, such regulatory instructions to companies would probably have routinely been handled through public warning letters. The growing use of untitled letters for such purposes spares recipient companies some embarrassment and possibly induces better company cooperation by being less publicly chastening. At the same time, however, such use deprives interested bystanders of the education that comes from watching others' mistakes being made and corrected.
As a matter of fairness, when FDA releases untitled correspondence under FOIA it should also provide the recipient companies' responses. DDMAC has been doing this but PAPS did not, at least in this first instance. This may not be PAPS's fault, however. FOIA requesters should explicitly request not only FDA letters but also the company responses.
James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry.