Friday, April 08, 2011

Time to Retire “Post-Marketing”?

FDA’s recently published guidance on Post Marketing Studies and Clinical Trials is a study in the importance of the mot juste.

The guidance defines two crucially different regulatory concepts: (1) post-marketing commitments (or PMCs, but better known as Phase IV studies), which have long been a staple of the drug approval process; and (2) post-marketing requirements (or PMRs), studies that are mandated by FDA under authority granted to the agency in the FDA Amendments Act. The guidance also elucidates the differences between “studies” and “trials,” as FDA sees it, since Congress used those terms—apparently intentionally—to distinguish between two types of, um, studies.

We aren’t going to explain all of those differences here. (You can read the guidance here, and coverage in “The Pink Sheet” DAILY, here.)

Instead of asking whether these activities are called studies or trials or commitments or requirements, we want to know why they are called “post-marketing”?

That term has been around for a long time, and was useful in the regulatory context to distinguish between “pre-marketing” trials, where the only way to access the drug is on an experimental basis, and the fundamental question of risk vs. benefit has yet to be definitively answered. In that sense, the term “post-marketing” trials suggests that the goal is to gather new information about a product already deemed safe and effective in at least some patients.

But use of the term “post-marketing” has become standard to distinguish between essentially anything FDA does during a product review (“pre-approval”) and what it does after an application is approved.

That difference used to be crucial, since FDA’s post-approval powers were distinctly limited compared to the power to grant (or withhold) approval in the first place. Moreover, when Prescription Drug User Fees were created, they were explicitly not supposed to fund “post-marketing” activities.

That has all changed. First, user fees are now used for many post-approval activities. More importantly, FDAAA gave FDA a host of new authorities to regulate real world use of medicines (REMS are the most prominent, but also new authorities over advertising, the ability to dictate labeling changes, mandatory safety assessments of new molecules after 18 months, etc.).

Those authorities are routinely described as new “post-marketing” safety tools. Here’s the thing: what FDA is actually doing is regulating the marketing of drugs. There is nothing “post-” about it.

The semantics matter because the label “post-marketing” helps perpetuate the fiction that the commercial life of a product is somehow separate from its clinical development. R&D organizations embrace (however reluctantly) the notion that FDA is a key customer: a primary goal of the clinical development plan has to be to satisfy FDA’s always evolving expectations for benefits versus risks.

But commercial organizations too often view FDA’s role solely as that of a mere traffic cop. No marketer wants to run afoul of FDA’s rules, but few actually embrace the idea that what they do—marketing—is now irrevocably a part of the FDA regulatory structure.

The agency’s review of new drugs routinely involves consideration of risk management plans and the imposition of potentially onerous research obligations on sponsors. The line between “pre” and “post” just isn’t what it used to be.

So let’s stop talking about “post-marketing” authorities to describe FDA’s new reach into commercial activities. FDA is regulating marketing.

As a side benefit, that allows “post-marketing” fill a new niche: describing the part of the product lifecycle after a drug has been withdrawn from the market. Because, alas, one implication of the evolving regulatory model is that more and more products will eventually find themselves entering that phase.

1 comment:

Trademark Litigation said...

The researchers looked at tests being done as part of “post-market surveillance studies,” which test products that are already approved and in general use by the public.

They found that patients who had small mesh tubes, called stents, placed into their neck in these studies were healthier than other patients in a broader nationwide registry of people who received stents.

“We were surprised,” said Dr. Robert Yeh, the lead author of the study and a cardiologist at Massachusetts General Hospital and Harvard Medical School.