|John F. Kamp serves as executive director of the Coalition for Healthcare Communication (New York City), a trade association that represents the healthcare marketing industry in Washington, DC. He is also of counsel to the law firm of Wiley Rein LLP (Washington, DC).|
Medical device marketers have long and warily watched the developing battles over regulation of pharmaceutical marketing, hoping that the lower profile of the device industry would enable them to avoid the most onerous of the restrictions proposed for drug marketing.
Those hopes may be dashed this year as Congress reauthorizes the Prescription Drug User Fee Act (PDUFA) and FDA fights to prove to the American people that it's a powerful and potent protector of consumers.
To enable FDA's drug center to keep operating, the reauthorizing legislation for PDUFA must be passed by October 1. Such must-pass bills frequently become vehicles to which every member of Congress feels entitled to attach his or her favorite proposal, and PDUFA is likely to become a textbook example of the practice. For starters, it's almost certain to incorporate reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA II), including the new user fees and agency performance goals recently negotiated between FDA and industry. But other proposals that are likely to become part of the 2007 version of PDUFA may not be so friendly to industry.
Legislation on the Fast Track
Among the proposals that are likely to be most important in the long runfor citizens and device marketers alikeare those intended to give FDA sweeping new powers to regulate the marketing of approved drugs. In the wake of the safety and marketing issues raised by Merck's 2004 withdrawal of its Cox-2 inhibitor Vioxx, voters are nervous about drug safety. Consequently, Congress is also focused on drug safety. Major bills in both the Senate and the House include sweeping new FDA authority to impose marketing restrictions on drugsand maybe devicesin the name of safety.
In the face of the October deadline, the proposed legislation is moving very quickly. In late April, the Senate Health, Education, Labor, and Pensions Committee (HELP) passed the Food and Drug Administration Revitalization Act.1 Introduced by Senators Edward Kennedy (DMA) and Michael Enzi (RWY), the HELP version requires all television drug ads to receive prior approval from FDA, permits FDA to impose a ban on direct-to-consumer (DTC) ads during the first two years after a drug's approval, and authorizes new marketing limits on all drugs as part of risk evaluation and mitigation plans. Advertising industry lobbyists are working to soften these provisions, and Senator Pat Roberts (RKS) has introduced an amendment that would strike most of the provisions but give FDA authority to impose civil fines on manufacturers that repeatedly violate the agency's marketing rules.
Whatever happens in the full Senate vote, the legislative focus will then shift to the House, where the lead proposal is characterized by one lobbyist as "Kennedy-Enzi on steroids." The Enhancing Drug Safety and Innovation Act, introduced in the House this March by Representatives Henry Waxman (DCA) and Ed Markey (DMA), gives device marketers something to really fear.2
Waxman-Markey offers FDA even greater power to require risk management plans, increases the ban on DTC advertising to three years, requires unique labeling and disclosures for all new drugs, and requires drug manufacturers to submit their marketing plans to FDA for review and approval. Once a company's marketing plan must be submitted for FDA approval, it's safe to assume that any changes to the marketing plan will also need to be sent to FDA. And some stamp of approval might then be required before the plan can be implemented. In short, the rules proposed to the Waxman-Markey legislation could make drug marketing very interestingand very complicated.
The DTC Debate
So far, most headlines related to the proposed legislation have been focused on its new requirements for DTC advertisingthe aspect of drug marketing that voters and legislators all think they understand (but probably don't). In addition to creating practical issues for drug marketers, however, the DTC proposals also raise First Amendment issues of censorship and prior restraint--areas that the Supreme Court has previously ruled out of bounds for FDA regulation. As these DTC provisions are debated in both houses of Congress, industry can expect to hear plenty of noise about censorship and the First Amendment.
The current legislative proposals are focused on drug marketing, and especially on the perceived abuses relating to DTC advertising of drugs. Medical device marketersespecially those whose companies make little use of DTC advertisingmight therefore be lulled into believing that the proposed legislation has little to do with them. In fact, however, executives for medical device and biologics firms still have plenty of reasons to be concerned.
Marketing regulation for drugs and biologics is now consolidated in the Division of Drug Marketing, Advertising, and Communication (DDMAC) at FDA's drug center. But while the device center has a separate marketing regulation unit and shares jurisdiction with the Federal Trade Commission, its policies for restricted devices closely track those of DDMAC. Moreover, once in place for one species of regulated product, FDA regulations have a way of migrating to other regulated industries.
The DTC advertising bans included in the proposed House and Senate bills may very well dieeither in Congress or in the courtsover First Amendment concerns. But no matter what happens with regard to DTC advertising, Congress and the American people want FDA to have more power to ensure drug safety. So, although there may be lots of noise as the DTC provisions are debated in both houses, there may not be very much discussion about the other new powers proposed for FDA.
Indeed, it seems entirely likely that the risk evaluation and mitigation strategy proposals included in the current versions of the House and Senate legislation may pass largely intact. In the hands of FDA, these proposals represent a weapon that is potentially much more powerful than any of the proposed tools for regulating marketing. And if these proposals are enacted into law, it's almost certain that the emerging regime for risk management programs will be applied broadly across the spectrum of FDA-regulated products.
Risk management programs are designed to limit marketing, distribution, and use. By design and intent, such programs are expected to hurt the sales of new products. Consider the risk-map programs that FDA has already imposed to limit the sales of such drugs as Accutane, Thalidomine, and Symlin. For example, when FDA finally approved Symlin in October of 2005, after multiple delays, it did so conditioned on the 'voluntary' promises of Amylin Pharmaceuticals (San Diego) that the company would forgo all DTC and professional advertising for two years, limit detailing to specialists with certified education, limit pharmacy distribution, and so on.
Although Congress has never explicitly authorized such risk management programs, FDA is already using them in a few of the most risky situations. If Congress does act to authorize such programs, industry can expect that the newly empowered FDA will use them much more broadly and aggressively.
Indeed, it would not be surprising to see FDA making more extensive use of such risk management programs over the next few months, even while Congress is debating the larger issues. Policymakers largely agree that FDA should be more aggressive, so few will quibble if the agency acts in the interim.
But watch out. Although such unauthorized risk management programs are now being used only for drugs, they could just as easily be attached to the approval of virtually any new regulated productincluding medical devices and biologics.
Because what happens to drugs can easily migrate to devices, medtech manufacturers should watch Congress with intense interest over the next several months. But at the same time, company leaders also need to keep an eye on FDA.
These days, it is taking longer and longer to develop medical products and get them through FDA's approval processes. And if current trends continue, companies can expect that even their approved products will face increasing limits on marketing.
Such changes can take place almost overnight. And without continued industry vigilance, they can even happen without much public discussion.
1. Food and Drug Administration Revitalization Act [reported in Senate] (S. 1082).
2. Enhancing Drug Safety and Innovation Act of 2007 [introduced in House] (H.R.1561.IH).