I was thrilled to hear that some of our elected members of Congress are finally working on proactive legislation that might benefit all of us.  This is especially encouraging after watching with much discouragement the high level of discord and dysfunction that has become commonplace in the Capitol.

Recently, some forward-thinking members of the Senate and House of Representatives introduced a bill to address the problems created by the United States Supreme Court in the Pliva v. Mensing decision last year. This controversial decision granted virtual immunity to the manufacturers of generic drugs for the safety of their products.  This decision should be troubling to consumers and taxpayers, as they will be the ones who ultimately bear the costs of injuries and harm caused by these manufacturers and their defective products.

The injured plaintiffs in the Mensing case developed tardive dyskinesia after taking the popular drug Reglan (also known as metoclopramide) for a prolonged period of time.  The antiquated labeling did not provide sufficient information about the likelihood of serious safety issues when metoclopramide was used for more than a few months.  Despite knowing that the drug was likely to cause tardive dyskinesia when used long-term, it was aggressively marketed by generic drug companies for use in the treatment of chronic conditions such as gastroesophageal reflux (GERD).

The companies that originally developed Reglan and published the first warning labels for the drug had essentially stopped marketing the medication by the 1970s as generic formulations became available.  The warning labels for the generic versions that were heavily marketed since the 1970s, however, did not reflect the current state of scientific knowledge over serious safety issues associated with the drug, especially when used long-term by patients.  Over the years, scientific studies have shown that as many as 29% of patients taking Reglan or metoclopramide develop tardive dyskinesia, a severe and debilitating neurological disorder that involves facial tics, involuntary limb movement, impaired ability to walk, and other serious physical limitations.   Sadly, this information did not reach most patients until 2009 when the FDA (rather than the drug companies) published a safety alert for prescribing physicians and patients to discourage continued long-term use of Reglan and metoclopramide.

While the history is quite complex, the issue behind the Mensing decision by the Supreme Court relates to the differing federal requirements for labeling of brand name versus generic prescription drugs.  Brand name manufacturers are required to update the warning label as new information emerges, while generic companies are supposed to copy the brand name label.  When the brand name drug is no longer marketed, however, federal drug labeling law fails to adequately protect consumers.   Obviously, generic drug companies could have asked the FDA for permission to update their labels or made certain that everyone knew of the latest safety issues, but that did not happen with Reglan (or other generic drugs being ingested by millions of consumers with inadequate safety warnings).  The Supreme Court’s decision did nothing to fill these holes, nor perhaps could they, but instead granted immunity to Pliva and other generic drug manufacturers. Mensing has also created serious safety issues for patients at a time when patients are being forced to take generic drugs by governmental and private health insurers.

The bill introduced in the Senate earlier this month  entitled “Patient Safety and Generic Labeling Improvement Act” (S. 2295) would restore sanity and require generic drug manufacturers to live up to the same standards as those required of brand name manufacturers, a simple concept that has vexed our legal system and federal government for years.  This legislative tweak would permit generic drug companies to update their own warning labels for their generic formulations of brand name drugs.  The Senate bill was introduced by Senator Patrick Leahy (D-VT) and is co-sponsored by Senator Al Franken (D-MN), Jeff Bingman (D-NM), Sheldon Whitehouse (D-RI), Sherrod Brown (D-OH), Christopher Coons (D-DE), and Richard Blumenthal (D-CT).

Representative Bruce Braley

A companion bill (H.R. 4384) was introduced in the House of Representatives by Rep. Bruce Braley (D-IA), who has long been a champion of patients’ rights, and Chris Van Hollen (D-MD).  Hopefully, we can count on other members of Congress who are strong advocates for patient safety and corporate responsibility to sign on as additional co-sponsors of these bills. Patients everywhere need to contact their members of Congress and request their support, as it is important that we hold generic drug makers responsible for the harm that they cause rather than shifting their burdens to taxpayers.

Public Citizen has also filed a petition with the FDA encouraging changes in the Agency’s guidelines as a solution to a problem that has been permitted to exist for too long at the expense of patients.  The FDA, as it is so prone to do, has promised to study the issue further.  Hopefully, they don’t want too long before doing the right thing.   The American Association for Justice has been strongly supportive of the efforts of both Congress as well as Public Citizen to level the playing field between generic and brand name drug manufacturers and to ensure that patients and taxpayers no longer suffer as a result of this drug regulatory blunder.

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