"The real losers from this attempted power grab would be the millions of Americans who depend on safe drugs. Without the protection of state laws Big Pharma can ride shipshod over Americans who are injured by their unsafe drugs. That's unacceptable and I'm seeing even conservative judges resist it."
Many members of Congress have also weighed in on the issue and reaffirmed that Congress never intended to preempt State claims in a February 23, 2006, letter to Michael Leavitt, Secretary of Health and Human Services, from Representatives Henry Waxman (D-Calif.), John Dingell (D-Mi.), and Sherrod Brown (D-Ohio).
Rep. Maurice Hinchey (R-NY) and Senator Edward Kennedy (D-MA), have threatened to fight preemption through legislation if necessary. Rep. Hinchey issued a press release on January 18, 2006, immediately after the policy was announced, stating that the "FDA has once again gone to bat for the drug industry by fully endorsing a policy that shelters pharmaceutical companies from Americans who want to file lawsuits because a drug has made them or a loved one seriously ill, or in some cases caused death."
Rep. Hinchey also called it "the latest example of the FDA sticking its nose where it does not belong and treating the drug companies as clients rather than regulated entities."
The FDA's language on page 38 of the preamble that states "whether it be in the old or new format, the Food, Drug and Cosmetic Act preempts conflicting or contrary state law," appears to imply that the preemption policy is retroactive.
Part of the language also says that lawsuits against doctors are preempted for failure-to-warn patients of risks associated with a drug, apparently even when a drug is prescribed "off-label," for a use other than those approved by the FDA.
"Pre-emption would include not only claims against manufacturers," the FDA states, "but also against health-care practitioners for claims related to dissemination of risk information to patients beyond what is included in the labeling."
The FDA has never before, in its entire history, claimed that a drug label preempts actions against health care professionals for failure-to-warn patients about risks. In fact, labels carry no information about the risks or benefits of "off-label" uses.
Critics see this language as an attempt to immunize all the doctors who the industry has convinced to over-prescribe drugs to treat conditions or patient populations for which the drugs have never been approved as safe and effective to increase profits.
"Doctors need to be held just as accountable as the drug manufacturers when things go wrong," attorney Kwok says.
"The profession of medicine is in danger of being totally co-oped by the business of medicine," he warns, "with more and more of the burden is being placed on the consumer."
"And with only minimum consumer protection standards set by the FDA, that isn't very reassuring," Mr Kwok notes.
"I predict there could be a flood of litigation," he says, "before FDA policy changes any more."
In any event, restrictions that the FDA places on drug labeling do not prohibit drug companies from disseminating warnings about a danger by other means. When it originally promulgated these regulations, the FDA made clear that:
These labeling requirements do not prohibit a manufacturer, packer, re-labeler, or distributor from warning health care professionals whenever possibly harmful adverse effects associated with the use of the drug are discovered. The addition to labeling and advertising of additional warnings, as well as contraindications, adverse reactions, and precautions regarding the drug, or the issuance of letters directed to health care professionals (e.g., "Dear Doctor" letters containing such information) is not prohibited by these regulations. 44 Fed. Reg. 37434, 37447 (June 26, 1979).
One of the main authors of the new labeling rules was the FDA's Chief Counsel at the time, Daniel Troy, who in previous employment fought the FDA in court to allow drug companies to promote drugs to doctors for "off label" use.
