FDANews Drug Daily Bulletin reported today:

The House Subcommittee on Health passed legislation renewing the Prescription Drug User Fee Act (PDUFA) and other provisions with few amendments after staff meetings resolved concerns including language eliminating the FDA’s preemption authority. The bill now goes to the House Committee on Energy and Commerce for a markup June 21.

That language would have said:

“Nothing in this act or the amendments made by this act may be construed as having any legal effect on any cause of action for damages under the law of any state (including statutes, regulations, and common law.”

It would have clarified that the FDA’s approval of a drug does not preempt a lawsuit brought under state law alleging that a drug company injured a patient who took a drug, or failed to warn them about risks of the drug. This would reverse the FDA’s attempt to establish that its authority preempts such claims, which we addressed earlier this week in this blog (“‘The Hill’ gets it (partially) wrong on FDA & Preemption”). Henry Greenspan addressed this further in an excellent post over at TortDeform.com (“Preempting Preemption: Will Congress have the will to state its will?”)

The FDA and industry had taken great pains to characterize this provision as a change in the law, rather than what it was, a restatement and reestablishment of long-standing practice regarding the FDA and preemption: that state law claims are NOT preempted by the FDA’s approval of a drug (except in Michigan, which has the most draconian law in the country on this subject, denying even the most grievously injured patients the right to sue drug makers).

With the House version of the bill going before the full Energy and Commerce Committee now mirroring the Senate bill in saying nothing on this, the issue seems to be a dead letter.

I predict that before the ink is dry on this bill we will see drug companies arguing in such lawsuits that the Subcommittee’s removal of this language somehow demonstrates Congress’s intent to have the FDA preempt all state law claims on personal injury and failure to warn. Legislative intent, like beauty, is so often in the eye of the beholder. Can we say that a Subcommittee’s removal of a proposed particular clarifying provision means that the entire Congress intended that its passage of a bill express the exact OPPOSITE? (I.e. “since the bill didn’t say that the FDA doesn’t have preemptive authority, then the FDA does have such authority”) That seems like one heck of a stretch, but stay tuned — it will soon be appearing in a Motion to Dismiss near you.

Last year, we gave one of our Bitter Pill Awards to PhRMA, The “Fox Guarding the Henhouse” Award For Pushing Toothless Voluntary Guidelines on Drug Advertising. This honor was bestowed on PhRMA in the wake of its promulgating vague and unenforceable “Guiding Principles” on drug advertising. As we said at the time, “the Guiding Principles do little to address the fundamental problems caused by DTCA. More importantly, they force the public to rely on the voluntary compliance of drug companies, an industry of which the public is justifiably suspicious.”

Well, you can remain suspicious, because PhRMA just released its second report on the complaints (or “comments,” as PhRMA describes them) received by its Office of Accountability concerning its members’ compliance with the guidelines. Other bloggers have ably reported on this, including Jim Edwards at BrandweekNRX, Ed Silverman at Pharmalot, and John Mack at Pharma Marketing Blog. And not surprisingly, the report is 11 pages of generalities and self-congratulation with nary a detail to be found — no description of the content of any actual complaint, what if anything the alleged violating company did in response, or what PhRMA will do in the future to address such violations.

Basically, the report is PhRMA telling us not to worry, they’re doing just fine, but no, you don’t need to know any details. This is what industry self-regulation always amounts to. But as drug scandal after drug scandal has shown, we cannot rely on the industry’s (ahem) honesty or its willingness to police itself.

With Congress having failed to pass even the most modest regulation of drug advertising in its recent votes on the reauthorization of the Prescription Drug User Fee Act, it looks like we’re in for another year (at least) of the Fox telling the Hens not to worry.

The Prescription Drug User Fee Act (PDUFA) reauthorization, passed last week by the Senate (but not yet by the House of Representatives) contained a wide variety of sections unrelated to FDA User Fees. One of these, section 519 would permit the FDA to impose monetary fines for pharmaceutical companies issuing “false or misleading” drug ads. The maximum fine for a first violation in a 3-year period would be $150,000, and a maximum of $300,000 for any additional violations in a 3-year period.

Back in 2005, PAL called for the FDA to seek from Congress the authority to issue civil monetary penalties, in our testimony at the FDA’s hearing on Direct-to-Consumer Advertising. Without such authority, the FDA’s power to regulate DTCA is essentially limited to issuing unenforceable “untitled” and “warning” letters. Given the number of recidivists in this area (see US PIRG’s report, “Turning Medicine Into Snake Oil“), this power is akin to an old joke (from Robin Williams, I believe) about unarmed British police shouting at a fleeing felon, “Stop, or I’ll Shout ‘Stop’ Again!”

It’s clear that for any standards regarding drug ads to be taken seriously, the FDA needs the ability to enforce them. Whether the fines included in the Senate’s PDUFA bill do the trick, however, is unclear. The fines listed are maximums, and even those are likely to be hotly contested by any companies upon whom they are sought to be imposed. It is uncertain whether fines in this amount would have any deterrent effect, or whether they might be, like much much larger US Attorney settlements recently reported upon here in this blog, slaps on the wrist. $150,000 is probably not far from the cost of a modest advertising buy on a major network, and certainly a small amount compared to even short-term sales of any blockbuster drug.

At the least, however, the notion that the FDA needs greater authority and powers to regulate drug advertising is now part of the public debate. And that is certainly a good thing.