Medical Device Daily Executive Editor

“Whatever happens to drugs, medical devices may follow.”

That’s an aphorism ... that we just made up.

And whether true or not, it is a concept that medical device makers probably need to consider over the next few months and years as it watches the FDA use the new powers it is likely to get with FDA reauthorization legislation.

The legislation won House and Senate approval last week and so now goes on to likely signing President Bush.

Earlier this year, lawmakers had pledged to quickly reauthorize the legislation and the user fees provision contained therein. But negotiations between the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor, and Pensions to reconcile the differences between the two bills dragged on throughout the summer, nearly leaving FDA without needed funds to pay reviewers.

After this debating and bickering, the two legislative bodies last week acted swiftly, the House on Wednesday approving it by an overwhelming 405-7 vote, and the Senate then late Thursday simply giving it the voice-vote nod.

(Was the quick action and likely fallout from non-action the result of Congress watching its public approval rating dropping close to the 10% mark? Probably – or maybe just not wanting to the wailings of FDA staffers threatened with lay-offs.)

The bill renews for five years the programs to collect fees from drug and device manufacturers to support the FDA’s costs for reviewing products seeking agency approval. It calls for drug companies to pay about $393 million in those fees next year, and medical device makers about $48 million.

The bigger story attached to movement of the bill to the president’s desk is the new, much broader powers provided to the FDA for post-approval surveillance of drugs – as well as some additional post-approval requirements for devices — a response to a key drug withdrawal and a variety of new concerns and black box warnings for several drugs over the past several months.

The FDA legislation would require all clinical trials on drugs, biologics and devices to be registered in a publicly accessible trial registry. Yet to be determined is the amount of information that will appear on that registry, how easily accessible and, finally, how informative it really is – in other words the actual level of disclosure.

Such disclosure ought to be of great benefit to the public, but as the saying goes (and an aphorism that we can hardly lay claim to), “the devil is in the details.”

The legislation includes the reauthorizations of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, provisions that the FDA has said provide valuable information concerning the impact of medical products on pediatric populations.

The bill contains a measure that would require firms to pay an additional $225 million in user fees over five years for drug-safety activities.

The legislation would require manufacturers to work with the FDA to develop risk-evaluation and mitigation strategies (REMS) before a drug is approved. The REMS are intended to help firms and regulators better assess post-marketing adverse-event reports and more efficiently communicate risk information to the public after a drug is approved.

And the legislation gives FDA the power to review television advertisements about drugs and biologics before the commercials are aired.

Currently, FDA reviews commercials submitted on a voluntary basis before they air or warns advertisers when the agency becomes aware of false or misleading information in an advertisement that has already aired. However, those warnings generally come after the advertisement has appeared for several weeks.

All in all, no one seems to be sure how many of these provisions will apply, immediately or eventually, to devices, but it is obvious that device makers need to monitor this carefully. All of these provisions will greatly increase post-approval costs of drugs, thus add to the pre-approval estimated at nearly $1 billion and more per new drug (always reflected at the pharmaceutical counter.)

The future moral of this story: Device manufactures probably need to exert every effort to police themselves in order to avoid this much policing by the agency – with many companies saying FDA surveillance is already over-arduous.

Following the two approvals of the legislation last week, both the FDA and AdvaMed (Washington) issued statements praising the congressional action, both statements pretty much being pro forma.

Andrew von Aschenbach, in the FDA statement, said that the PDUFA and MDUFMA programs “have resulted in significant public health gains by making safe and effective, yet increasingly complex, medications and medical devices available to patients faster than was previously possible.”

That statement is hardly plausible by any standard.

The agency is not keeping up with product complexity, and while its annual reports always claim faster approvals, the data provided always appears to us as (as the Brits would say) mostly jiggery pokery. And in healthcare terms, not significant, statistically or otherwise.

A statement from AdvaMed, with Stephen Ubl, president/CEO, praising the congressional actions, also came as no surprise.

AdvaMed has been the main driver behind getting and keeping the device user fee program, and it is in its best interests to tell the world – and the AdvaMed membership – that such fees are a good thing.

But the user fees are not the real question here – they are what they are. The question is the FDA’s activities, going forward, to implement the new legislation and answer a variety of questions, as follows:

How much usable information concerning the post-approval performance of drugs and devices will be provided to the public?

How easily accessible by the public will this information be?

How many of the FDA’s extended powers over pharmaceuticals will then also be applied to devices?

And what will be the ratio of additional costs to additional product safety?

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