The Gottlieb Declaration
As note Scott Gottlieb is an MD former employee of the FDA where he served as a senior adviser.
I do not get the sense that Gottlieb's declaration is in any way "whistle blowing". The bulk of his message is there are alternative ways to deal with the issue of "off label" promotion other than the FDA's attempt to squelch any information regarding an approved drug's potential benefit in an "off label" situation.
Gottlieb is a former "regulator" and he walks and talks like one. He offers a number of solutions..Control by the third party payers, creating a compendium of medical experts to rate the strength of the "off label" argument...and several other alternative solutions to the FDA's gag rule.
The problem here is once the FDA approves a drug, the FDA has little control of the way individual physicians use the drug, or for what disease conditions they use it for. To get an sNDA, (a formal FDA approval) for a new indication, is generally a long drawn out process (see R-IT) and the FDA's standards for approval are generally much higher than those of the clinicians using the drugs for new indications. The FDA wants sponsors to go through the sNDA process and fears they will not if they can successfully promote their drug "off label".
Gottlieb's alternative solutions for the most part have been rejected by JW as being impractical, or worse, and I agree with her. IMO opinion the solution is very simple when you include all the facts. The FDA assumes they are the sole overseer of physicians and protector of patients, and that is simply untrue. The group with the greatest control on physicians' behavior are the malpractice lawyers. Lawyers also monitor drug companies as can be seen in the numerous "bad drug" commercials seen on TV. Malpractice suits are like cobra bites to clinicians. Malpractice suits are a major cause of clinical depression in doctors. No practicing physician is going to prescribe a medication until they are familiar with the side effects and possible adverse effects. The reality is lawyers have much more control on doctors behavior, than the FDA.
The best solution to the "off label" dilemma is to allow things to take their course. Sponsors should be allowed to promote "off label" indications using truthful and non misleading statements. It is the doctors and their patients, and not the FDA that is at risk. The FDA should monitor the sponsor's statements for accuracy and certainly prohibit false or misleading statements. Well informed doctors are in the best interest of the patients. Well informed doctors are less vulnerable to malpractice.
FDA process is too slow and FDA can not keep up with the pace of new information. So is the FDA really helping patients if keeps a potential life saving drug like Vascepa off the market for four years simply because it wants to maintain control or retain its presence as a regulator. Medical advancement is slow enough without the FDA grinding it to a halt with its burdensome policies that can slow down things for years (see Vascepa).
Finally the FDA was created to protect the public against false advertising and dangerous drugs, and not to monitor commerce, or restrict legal speech...Perhaps it should be returned to that status.
":>) JL
