Medical Device Daily Washington Editor

If you work for FDA, you are probably familiar with the idea that you cannot win for losing.

FDA recently proposed to review manufacturer’s changes to drug and device warnings, an authority that was embodied in the FDA Amendments Act of 2007, but House and Senate Democrats are questioning the agency’s motives. One of the allegations in a Congressional letter to FDA on the proposal is that the proposed guidance “will serve only to deprive American consumers of critically important and timely information about the safety of their drugs and medical devices.”

However, a close reading of the FDA document makes clear that manufacturers can change the labels without the agency’s explicit approval only if supplemental paperwork is on file at the agency and the warnings are based on new information.

The Jan. 23 letter, signed by nine Democratic members of the House and Senate, alleged that “the intent of this proposal is to protect companies in the pharmaceutical and device industry from being held liable for marketing products they know are unsafe.” The letter, addressed to FDA chief Andrew von Eschenbach, MD, said that the policy change “comes at the expense of consumers and violates the mission of the FDA.”

Citing personnel considerations, the authors of the letter assert “[s]ince 1982, FDA’s funding situation has taken a dramatic turn for the worse,” describing FDA as “an agency that is all but starved of resources.” However, Congress has been notoriously silent in arguing for a boost to FDA funding, prompting the formation of groups such as the Coalition for a Stronger FDA (Washington).

The letter described the FDA funding situation as a “public health crisis” during which “the Bush Administration has turned its back on American consumers.”

FDA states in the proposed ruling that manufacturers can change labels upon submission of supplemental documentation, even if FDA has not had time to respond to those changes-being-affected documents so long as the additional warning information is based on new data on the drug or device.

The agency also notes in the guidance that “permitting a sponsor to unilaterally rewrite the labeling for a product following FDA’s approval of a product and its labeling would disrupt FDA’s careful balancing of how the risks and benefits of the product should be communicated.”

FDA also based its argument in part on the notion that “[e]xaggeration of risk, or inclusion of speculative or hypothetical risks, could discourage appropriate use of a beneficial drug, biologic, or medical device.” The agency also expressed concern that “labeling that includes theoretical hazards not well-grounded in scientific evidence can cause meaningful risk information to lose its significance.”

Alan Schwartz, executive VP for MDI Consulting (Great Neck, New York), told Medical Device Daily: “I think that what FDA is looking for is that they don’t want people adding more warnings without supplying a 510(k) update.”

Schwartz said that FDA “has seen too many companies add more warnings” in connection with problems with products in the field, and FDA is saying “we want to see those changes so we know what’s going on.”

“It would appear that FDA’s intent was to determine the cause of the updated warnings and determine whether those represent cause for a field correction. Maybe Congress is not fully aware of FDA’s intentions, assuming that’s the case,” Schwartz said.

Supreme Court to hear drug pre-emption

The Supreme Court indicated last week that it will take up the lawsuit against the Warner-Lambert unit of Pfizer (New York) for injuries associated with the diabetes drug Rezulin (troglitazone), a drug Pfizer pulled from the market in 2000. The case comes on the heels of the Court’s review of Riegel v. Medtronic, a case that the Court will decide on sometime before the end of the current session in June (Medical Device Daily, Dec. 5, 2007).

The Court’s interest in pre-emption is seen as a positive development by at least one observer, who pointed out that pre-emption law in the courts is pockmarked with inconsistencies.

The Rezulin suit was initially filed in 2000 in connection with a number of deaths (variously pegged at 155 and now more than 300) and hundreds of cases of liver failure associated with the drug. A federal district court in Michigan dismissed one such suit in 2005 because that state’s laws granted federal pre-emption of state liability cases, but the 2nd U.S. Circuit Court reinstated the case in October 2005. The product has been the subject of a number of suits in various jurisdictions over the past eight years.

The Supreme Court’s interest in both the Rezulin case and the Medtronic case suggests that the Court is interested in clearing out a confusing array of different outcomes for pre-emption that have dotted the legal landscape for the past 20 years.

Bill Kitchens, a partner with the law firm Arnall Golden Gregory (Atlanta), told MDD that the Supreme Court’s interest hints at how it might rule on the Medtronic device pre-emption case. “I would view it as a positive sign, but the parameters of how they will deal with pre-emption under devices is still an open question.”

Kitchens said that because device pre-emption is a statutory reality and that statutes make no similar mention of pharmaceuticals, there is no reason to assume an outcome. As for how the Court might decide on the Medtronic case, he said, “the opinion would be that it’s a pretty strong case for pre-emption given the way that the Act reads.”

Kitchens acknowledged that he was somewhat surprised at the Court’s willingness to hear the Rezulin case. “I think you have to be somewhat surprised whenever something hits the Supreme Court,” but pre-emption “has been so inconsistent,” the Court may be of the opinion that it is time to establish some sort of working paradigm for the legal community.

“I think they’re doing their job in bringing more consistency” to the law, Kitchens said.