U.S. Representatives Fred Upton and Diana Degette have a plan for getting drugs to market more quickly, embodied in the “21st Century Cures” bill. Among other concerns it raises, it allows drug and medical device companies to go to market with new products evaluated using lower standards of safety and efficacy than required today. The bill’s expressed goal of fostering medical innovation may sound good, but it in fact puts all patients at serious risk while helping the health care industry see greater profits.
First, the bill does an end-run around the US Food and Drug Administration, essentially compromising its role to ensure drugs and devices are reasonably safe and effective. As it is, the FDA has several mechanisms for speeding up the development and approval proces[s for new drugs and devices. But, the bill allows drugs to go to market with less evidence about safety and even without evidence on effective clinical outcomes.
Second, the bill only opens the door further to price gouging by drug companies (read here about pay for delay and here about exorbitant prices for cancer drugs and here about the latitude drug companies have to control prices) and higher hospital costs. It rewards pharmaceutical companies unduly for developing new antibiotics, allowing them effectively to set prices. And, it encourages hospitals to use these new antibiotics, through higher payments, without regard to either their costs or the risk of increased antibiotic resistance through their overuse or unnecessary use.
Third, the bill provides a handout to the medical device industry, weakening the approval process for devices such as prosthetic hips and knees. In fact, that process needs strengthening.
In short, nothing in the bill encourages the drug and device companies to address unmet patient needs. Rather it implicitly condones escalating prices for less safe and less effective products. But, the medical industrial complex is a big supporter of members of Congress and a tremendous supporter of Congressman Upton. The bill passed the House of Representatives in July. It goes to the Senate some time this fall.
To read more about why the Senate should not pass 21st Century Cures from Breast Cancer Action, click here.