I don’t know how the November elections will turn out, but I know that Democrats have lots of issues to run on – climate change, LGBT rights, immigration reform, war. Let’s add to that list the Robert’s Supreme Court. From deeply harming women’s rights, voting rights and affirmative action, to greatly expanding corporate power, this Court has created all kinds of problems for Americans. Many of these decisions have overturned longstanding laws for unsound reasons resulting in scathing dissents, particularly by Justice Ruth Bader Ginsburg (who isn’t going anywhere, by the way) and Justice Sonia Sotomayor.
And Democrats have pounced. An example is this statement from Democratic Congressional Campaign Committee Chair Steve Israel, a Congressman from Long Island, New York, following the Hobby Lobby decision. He decried the harm to women’s right to access quality health care. Good for him.
There have been plenty of other 5-4 decisions that have toppled other longstanding laws and generated scathing Ginsburg and Sotomayor dissents worthy of similar DCCC attention. So the very last thing I ever expected was finding out today that Rep. Israel has oddly decided to side with the industry beneficiary of one – actually two – of those 5-4 decisions: Pliva v. Mensing and Mutual Pharmaceutical Co. v. Bartlett, which together immunize the generic drug industry from liability. He also happens to be siding with all the big drug chains (CVS, Rite Aid, Walgreens and even Wal-Mart) against those working for quality health care, like the American Medical Women’s Association, Breast Cancer Action, Consumers Union (publisher of Consumer Reports), the National Research Center for Women & Families, the National Women’s Health Network, and the Unions of Concerned Scientists. And we should mention, against a large majority of Americans, since 80 percent of prescriptions today are filled with the generic version and generics are not as safe as you might think. And most immediately, against the Food & Drug Administration’s proposed rule to fix these decisions in response to a petition from Public Citizen.
In Mensing, the Court decided that current FDA regulations prevent a generic drug company from independently changing a drug label even if it knows that label to be inaccurate and out-of-date. Because generic companies have no power to make those changes, they cannot be held liable if a consumer is harmed or killed by a generic drug due to the drug’s inadequate labeling or defective design. In other words, the injured patient has no recourse. Yet, if the patient happens to take a brand-name version of the drug instead and is injured, the patient does have recourse! I mean, even the Court majority suggested this result was “bizarre” (their word), pointing out, “Congress and the FDA retain the authority to change the law and regulations if they so desire.” Talk about a problem calling out for a regulatory fix!
And there’s another big problem with current regulations, which charge only brand-name drug companies with ensuring safe and accurate labels. What happens when the brand name company removes its drug from the market after the generic comes in? This happens all the time. Here’s what could and sometimes does happen next: out-of-date safety information remains on the label and no one does anything about it. How is this any good? (Rep. Israel says this rule will result in temporary confusion. Completely untrue and even if it did, how is this a public health concern anywhere close to the one created by current rules that prevent generic companies from updating labels they know are unsafe? Learn more here.)
Justice Sotomayor issued a particularly blistering dissent in the Bartlett case, noting how the Court turned the law completely on its head for the purpose of protecting corporations from liability exposure and wiping out traditional state tort remedies. Moreover, as she pointed out, the majority’s reasoning “has the ‘perverse effect’ of granting broad immunity ‘to an entire industry that, in the judgment of Congress, needed more stringent regulation,’” leading her to call the majority decision “frankly astonishing.”
So, following the directive from the Court, the FDA has proposed this urgent safety rule change. Let’s hope it gets implemented quickly so all that generic drug industry lobbying money can be spent on more useful endeavors. American patients (and their physicians) should have the best safety information available – and that goes for our good friend, Rep. Israel, too. (In the end, I know he’ll appreciate this!)