Letter to Doctor Margaret Hamburg, Commissioner of the FDA - Labeling Regulations

Letter

Senate Judiciary Committee Chairman Patrick Leahy (D-Vt.) joined with Senate HELP Committee Chairman Tom Harkin (D-Iowa), Senator Al Franken (D-Minn.), and Representatives Chris Van Hollen (D-Md.), Bruce Braley (D-Iowa), Henry Waxman (D-Calif.), and Matthew Cartwright (D-Penn.) Monday to call for regulatory action by the Food and Drug Administration (FDA) in light of today's 5-4 Supreme Court decision in Mutual Pharmaceuticals v. Bartlett. The decision held that a New Hampshire woman who suffered devastating injuries after taking the generic version of an anti-inflammatory drug may not sue the generic manufacturer for her injuries, because her claim is preempted by federal law.

"Like the PLIVA v. Mensing case last year, this decision creates a troubling inconsistency in the law that penalizes the millions of Americans who take generic medications," said Leahy, who has long championed drug competition and consumers' access to less-costly generic versions of prescription medicines. "A consumer should not have her rights foreclosed simply because she takes the generic version of a prescription drug."

The decision in Mutual Pharmaceutical Co. v. Bartlett mirrors the Supreme Court's 5-4 decision in the 2011 case PLIVA v. Mensing, in which the majority held that manufacturers of generic drugs cannot be held liable under state tort law for inadequate labeling. Together, these cases mean that patients who take the generic version of a prescription drug may be left without a remedy if they are injured -- even though consumers who take the brand-name version of the drug may seek recourse for their injuries.

Leahy and other House and Senate lawmakers last year called on the FDA to address patient safety concerns in light of the Mensing case, by revising drug regulations so that generic manufacturers can improve the warning labels on their products when they receive new information, and can be held accountable if they fail to do so. Leahy, Van Hollen and other lawmakers introduced related legislation in the House and Senate last year. The lawmakers reiterated their call for FDA action again Monday:

"[Today's] decision compounds the harsh consequences of the Mensing case, further foreclosing legal remedies for patients who take the generic version of a prescription drug," the Senate and House members wrote. "Responsible brand-name and generic manufacturers alike should have the ability, and the obligation, to give doctors and patients the information they need to avoid injuries."

A copy of the letter to FDA Commissioner Doctor Margaret Hamburg is below.

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June 24, 2013
Doctor Margaret Hamburg
Commissioner, Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002

Dear Commissioner Hamburg:

We write to urge the Food and Drug Administration (FDA) to expedite its consideration of revisions to the FDA's drug labeling regulations to enable manufacturers of generic drugs to update patient safety labeling in appropriate circumstances. These changes are critically important to ensure that the public is adequately informed of the risks and benefits of prescription drugs, and that consumers who are injured by generic drugs have the same legal rights as those who are injured by the brand-name versions of the same drugs.

In the 2011 case PLIVA v. Mensing, the United States Supreme Court held that patients cannot hold generic drug manufacturers accountable for failure to warn of injuries associated with their products. As a result, consumers who are injured by the generic version of a prescription drug may be foreclosed from seeking any remedy, even though consumers who take the brand-name version of the drug can seek recourse for their injury. The Supreme Court based its decision on the FDA's statements that a generic drug manufacturer cannot revise its labeling to provide updated safety information, except to mirror a revision made by the manufacturer of the brand-name equivalent.

The FDA's statements and the Court's decision raise serious concerns about patient safety and accountability for manufacturers. Almost 80 percent of all prescriptions are filled by the generic version of a drug. Although existing FDA regulations require generic manufacturers to collect adverse event information, generic manufacturers are not permitted to strengthen their labeling information to respond to such data. We urge the FDA to revise this position and amend its labeling regulations so that generic manufacturers may participate fully in the labeling process, using a process akin to the Changes Being Effected process that is available to brands.

In April 2012, several signatories of this letter introduced legislation in the Senate and House of Representatives that would permit manufacturers of generic drugs to update their labeling to provide additional safety information, in the same way as the FDA permits brand-name manufacturers to do. We were encouraged by the FDA's announcement in January 2013, in its Supreme Court amicus curiae brief in Mutual Pharmaceutical Company v. Bartlett, that it is considering a regulatory change along the lines of that legislation. Unfortunately, we have yet to see any action from the FDA on this matter. In the meantime, the safety gap created by the current regulations and the Supreme Court's decision continues to put patients at risk.

The facts of the Bartlett case illustrate the gravity of the problem. Karen Bartlett was severely injured after taking a generic drug, sulindac, that was prescribed for shoulder pain. Clinoril, the brand-name version of sulindac, was approved in 1978, and generic versions came to market beginning in 1988. Sulindac poses a risk for patients of a devastating condition known as Stevens-Johnson Syndrome/toxic epidermal necrolysis (SJS/TEN), a potentially deadly disease involving damage to the skin and mucous membranes similar to the damage caused by severe burns. When Ms. Bartlett was prescribed sulindac in 2004, the warnings section of its labeling did not mention SJS/TEN. Ms. Bartlett subsequently contracted the disease, with devastating consequences, ultimately losing 60 to 65 percent of her skin. She is now permanently disabled, with extensive damage to her lungs and esophagus, and is legally blind despite 13 eye operations. It appears that little was known about the association between SJS/TEN and sulindac at the time of its initial approval: as is often the case, information about the extent of the risk came to light only through post-marketing adverse event reports. Since 2005--too late for Ms. Bartlett--the FDA has required manufacturers to include a strengthened SJS/TEN warning on sulindac.

The Bartlett case is one example of many that show how the longevity of a drug on the market is no guarantee that all of its risks are known to the public or to the doctors on whom patients rely--even when manufacturers are or should be aware of those risks. There is an imperative need for all drug manufacturers to remain vigilant about adverse effects and to have the ability to update their labeling to disclose risks when they become known, so that drugs can be used as safely and effectively as possible.

Today, the United States Supreme Court issued its decision in the Bartlett case. The Court held that Ms. Bartlett, despite her severe injury, could not sue the drug's manufacturer for defective design--again, because she received the generic version of the drug. Although the principal issue in this case involved "defective design" instead of "failure to warn," the decision compounds the harsh consequences of the Mensing case, further foreclosing legal remedies for patients who take the generic version of a prescription drug. This outcome penalizes the millions of Americans across the country who rely on the generic versions of prescription drugs, and jeopardizes our nation's commitment to promoting safe, affordable generic medications.

We urge the FDA to expedite its review of the current rules governing generic drug labeling changes and promulgate regulations to ensure that generic drug manufacturers can improve the warning information for their products in a manner similar to that available to brand-name manufacturers. Responsible brand-name and generic manufacturers alike should have the ability, and the obligation, to give doctors and patients the information they need to avoid injuries.

Sincerely,

PATRICK LEAHY
CHRIS VAN HOLLEN
TOM HARKIN
BRUCE L. BRALEY
AL FRANKEN
HENRY A. WAXMAN
MATT CARTWRIGHT

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