Serious Safety Hazards often Take Years to Emerge

A Public Citizen report today points out that many of a given drug’s side effects are not discovered until several years after the drug has been on the market.

Reglan (generic: metoclopramide), for one, was on the market for nearly 30 years – its brand version had become virtually unavailable – before it received a black boxed warning in 2009, too late to warn hundreds of people who had already contacted the incurable movement disorder of tardive dyskinesia.

Reglan is far from alone.  “At least 53 drugs approved by the Food and Drug Administration (FDA) more than 10 years ago have required new black-box warnings over the past five years,” says the new Public Citizen report.

Generic drugs now constitute as many as 80 percent of all filled prescriptions. In many cases, generics have taken the majority of market share of a given drug for a decade or more, yet the Supreme Court has refused to hold those corporations accountable when their products have caused injuries.

The FDA’s inaction on generic drug makers’ responsibilities, meanwhile – especially as the Supreme Court gives generics a free pass when they injure people – is startling. The agency has essentially sat on its hands in allowing generic drug companies extraordinary profits, while the Supreme Court has given them near total immunity from liability. So who is looking out for the consumer? Public Citizen lists 434 generic drugs for which no brand-name product yet remains on the market.

“Generic drug manufacturers’ inability under current regulations to update the labeling of their products poses a threat to the safety of prescription drugs, creating unnecessary risks to patients,” said the director of Public Citizen’s Health Research Group, Dr. Michael Carome.

Of the 53 drugs which required a black box warning after being on the market for a decade, according to Public Citizen, “11 are available only as generics, while 38 are still marketed in both brand-name and generic versions. One is sold only as a brand-name drug, and three are no longer sold at all.

Similar to Reglan, writes Public Citizen, “Darvon was first approved for pain relief in 1957 and Darvocet in 1972. The FDA called for an additional black-box warning in 2009 due to the risk of overdose when used with other pain medications. At the FDA’s request, manufacturers took the drugs off the market in 2010 – 53 years after Darvon first came onto the market – citing the potential to cause serious heart damage.”

Public Citizen submitted a citizen petition to the FDA in 2011 requesting the agency amend regulations to let generic drug manufacturers follow the same protocol for updating labeling that brand-name drug makers follow. The FDA has yet to answer the petition.

The citizen’s group also points out that “because the U.S. Supreme Court held in PLIVA, Inc. v. Mensing in 2011 that a patient harmed by a generic drug that had inadequate labeling cannot sue the manufacturer for compensation for her injuries, revised regulations would correct the illogical disparity between the rights of patients injured by generic drugs and the rights of those injured by brand-name drugs.”

That hotly-disputed Mensing decision was followed up today by another partisan (5-4) Supreme Court decision in Bartlett, which again gives generic drug companies little to no incentive to monitor the safety of their drugs and protect the people (us consumers) who yearly put billions of dollars into the generic drug company coffers.

by Matthews & Associates