One of Nelson Mandela’s enduring legacies was raising awareness about HIV/AIDS and he is one of the prominent figures featured in a new documentary film called Fire in the Blood, which premiered this year at Sundance. The film “tells the story of how Western pharmaceutical companies and governments aggressively blocked access to low-cost AIDS drugs for the countries of Africa and the global south in the years after 1996 - causing ten million or more unnecessary deaths - and the improbable group of people who decided to fight back.” This film follows last year's Oscar-nominated documentary, How to Survive a Plague, which told a similar story about how two coalitions, ACT UP and TAG (Treatment Action Group), fought Big Pharma here in the U.S.
It typically takes 20 years for brand-name drug patents to expire during which time we are all patently price-gouged by drug companies. (Pardon the pun.) The grotesque profit-driven priorities of Big Pharma to keep affordable drugs out of the hands of desperately ill people should make us all grateful for lower-cost generic drugs And usually we are.
But what if a generic drug is unsafe? This happens more than you might think, according to a new White Paper from the Center for Justice & Democracy called America’s Unaccountable Generic Drug Industry; How Legal Immunity Could Be Making You Sick.
As we’ve noted before, right now, the generic drug industry has complete immunity for marketing drugs it knows to be unsafe. This is thanks to two recent U.S. Supreme Court decisions, where the Court ruled that if a consumer is harmed or killed by a generic drug due to the drug’s inadequate labeling or defective design, the manufacturer cannot be held accountable in court; the injured patient has no recourse. The same immunity does not apply to the brand-name drug industry. But today, 80 percent of the time you end up with the generic version of whatever your doctor prescribes.
Here are some other fairly disturbing things that CJ&D found:
- Despite what is commonly believed, generic drugs sometimes do not match their brand name counterparts and patients who take them can suffer health consequences due to unsafe design, labeling or manufacturing.
- To keep costs down, the FDA approves generic drugs without independent testing if they believe the generic drug is “bioequivalent” to the brand-name drug, but this determination is sometimes flawed.
- To keep costs down, generic drugs are more likely than their brand-name counterparts to be manufactured overseas, in countries like India and China, where the FDA rarely inspects factories or the supply chain. History shows that generic drugs or ingredients can be manufactured in dilapidated, dirty factories.
The FDA has now taken steps to modify its regulations, so at least the generic drug industry would be fully accountable for the safety of its drug labels. Comments on this new proposed rule are due January 13, 2014. Time to weigh in, people!