H.R. 6, the so-called “21st Century Cures” Act, contains a provision – written by Big Pharma lobbyists – that would give manufacturers of prescription drugs a six-month extension on exclusivity. What this means is that it would give drug makers an additional six months to charge whatever they like for potentially life-saving medications without having to worry about competition from generic versions.
The good news is that people are on to this boondoggle. The bill has since gone to the Senate. However, since Big Pharma’s psychopathic greed has been shoved in our collective faces over the past months, Congressional Democrats, pressured by a coalition of liberal organizations that include the AFL-CIO and others, have been pressuring their colleagues to pass legislation that would rein in the drug companies’ extortion – putting the fate of the “21st Century Cures” Act in doubt.
Now, for the bad news: there is a good chance that Congress will shove this bill through after the election – during the lame duck session, when there is little accountability to constituents.
The bill originated with the House Energy and Commerce Committee in April of 2014, when that committee launched an initiative to speed up the FDA approval process for new medications and treatments for conditions that have no such treatments at present. The original bill was nearly 400 pages in length. Today, it is half that as legislators have continued to cut out various proposals over the months.
Supporters for the bill say that it will provide more funding for medical research as well as incentives to the drug industry to develop treatments for more uncommon diseases. It would also expedite the FDA approval process for new medications. On the surface, this seems like a good idea that would save lives and improve the quality of life for all of us. However, keep in mind that Big Pharma doesn’t give a tinker’s damn about anything but maximizing its profits. It’s a state of affairs that is unique to what is possibly the worst health care system in the industrialized world – a system that is still profit-driven and in the control of private corporations.
In fact, the FDA already has an “expedited process” for approving “new” drugs and medical devices. It’s called the 510(k) Pre-Approval Process. All a drug company or medical device manufacturer has to do is demonstrate that its “new” product is “substantially similar” to an older one already approved for the market. If the number of “pre-approved” drugs and devices that been harming and even killing patients is any indication, that hasn’t been working out so well. In a 2015 article in the New England Journal of Medicine, doctors expressed serious concern that any “expedited approval” process under the 21st Century Cures Act would lower standards, compromising drug safety while having virtually no positive effect on patient outcomes.
Do we really need more of the same?
However, the real kicker – the $12 billion giveaway to one of the greediest and most predatory industries on the planet – are those “exclusivity provisions,” allowing drug companies to keep a lock on their patents for an additional six months. It will give Big Pharma that much longer to continue price gouging and withholding those life-saving treatments from those who cannot cough up the price – while continuing to siphon our tax dollars into their private coffers.
Acknowledging that the bill lacks universal support, particularly among Democrats, House Minority Leader Nancy Pelosi – who, unsurprisingly, supports the bill – says, “We’re just going to have to build consensus.”
And the best time to do that is during the lame duck session after next week’s election – when constituents aren’t always paying attention and legislators have nothing to lose by ignoring them.