A Bill Would Give The FDA Mandatory Recall Powers
8 CommentsBy Ed Silverman // July 20th, 2010 // 9:47 am
In light of the Johnson & Johnson recall scandal, the House Committee on Oversight & Government Reform has, as promised, introduced a bill to give the FDA mandatory recall powers. The move comes after Ed Towns decried the way J&J’s McNeil Consumer Healthcare unit responded to repeated quality control problems that led to the recall of tens of millions of over-the-counter pediatric meds (back story here, here and here).
Under the legislation, which amends the Federal Food, Drug and Cosmetic Act, the FDA would have the authority to demand a recall when there is an indication that a drug has been adulterated, misbranded, or exposure to a drug may cause serious adverse health consequences or death to humans and animals (here is the bill). The J&j products, which the healthcare giant is scrambling to produce elsewhere while its Fort Washington, Pa., plant is shutdown indefinitely, were found to have a musty smell, metallic flecks or too much active ingredient. Towns accused the McNeil unit of conducting a phantom recall in hopes that regulators and consumers would not be alerted to the problems.
pharmavet
The law as proposed simply will not pass. It gives to the Secretary of HHS certain powers that is not within the legal scope of the office. The Secretary has such authority only under conditions of a national public health emergency. The vast majority of cases of misbranding or adulteration do not rise to this level. Ms. Sebelius has already demonstrated her willingness to circumvent FDA and abuse her powers by granting immunity to certain vaccine makers, again clearly overstepping the legal boundaries of her office. This is not surprising, since the White House “Czars” that currently hold office operate more like Russian oligarchs than commissioners answerable to the general public.
Technically Sebelius could consider every drug on the market as misbranded. The reason is that every package insert is updated at regular intervals with new safety information. During the update the product currently on the shelves has the “old” PI and could be misbranded. Only one reason why Sebelius’ powers should not be enlarged.
Condor
Hello pharmavet –
Your view of Ms. Sebelius’s statutory authority is flawed. This proposed bill would give her the authority — and there is no serious constitutional argument to prevent the OCngress from giving her this power:
“. . . .SEC. 568. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF CERTAIN ADULTERATED OR MISBRANDED DRUGS.
(c) . . . .If the Secretary has reason to believe that the use or consumption of, or exposure to, a drug (or an ingredient or component used in any such drug) may cause serious adverse health consequences or death to humans or animals, the Secretary shall have the authority to issue an order requiring any person who distributes such drug —
(A) to immediately cease distribution of such drug. . . .”
I think some form of the above will in fact pass, after the latest JNJ, GSK and BAX debacles.
Namaste
Condor
Oops! Buried the punchline:
So the proposed mandatory recall power would only cover cases involving “”serious adverse health consequences or death to humans or animals. . .”
Not the simple labeling matters suggested by pharmavet. [So sorry for the iPhone 4 typos above.]
Namaste
Justice in MI
I’m probably not the only one amazed that FDA doesn’t already have that authority in the context of these conditions. They do re: tainted food, yes?
Anne PME
Thanks for posting this.
Questions:
Are there any legal issues such as practicing w/out a license b/c this HHS Secretary and other Secretaries are not licensed medical professionals?
Prescription drug recalls seem different b/c many of these medicines are distributed by drug wholesalers and paid for (reimbursed) by patients and PBMs/plans.
Salmon
Not having a license is not an issue as this is not practicing, i.e. the secretary is not seeing individuals patients in a professional capacity.
The current law says secretary for a variety of things including drug approvals. Which of course are delegated functions. So why is this even a concern with drug removal when the secretary is already legally responsible for the reviews and approvals.
The secretary also already has the legal authority to completely remove drugs from the market under certain circumstances. This would be an intermediate level for slightly different circumstances. It also eliminates certain problematic aspects of the current law whereby even in a case of complete market removal there are several steps including having to go to court that would no longer unreasonably delay removal from distribution.
I believe that currently a drug can be immediately removed from the market for fraud but not for safety.
Salmon
pharmavet
Ms Sebelius is a former state insurance commissioner. Therefore she does indeed have experience practicing medicine without a license. Anne, your question is spot on. There are indeed MD’s in high level positions in the administration. Dr. Regina Benjamin is currently Surgeon General of the United States. Dr. Zeke Emenual is an ex officio advisor to the administration. Even President Bush had the intelligence to appoint an MD (who was also a PhD) to head HHS. Like these examples there are many superbly qualified MD’s with experience with both drug safety and Public Health in the FDA who could be consulted, but they are not, since why mess up politics with science.
Sebelius holds a Masters Degree in Public Administration. This hardly qualifies her to make decisions, for example, that might concern “adulteration of product”, which many times are not obvious and should be ruled upon by individuals with the proper technical background, not by a political appointee.
harpy
I’m with you JiM - why don’t they have that power already? after all, FDA approval is permission to market a drug or device. they oughta be able to revoke it.