When a new heart valve was approved by the FDA in July, it gave thousands of heart patients too sick to undergo surgery a better chance at survival.
That’s the good news. The bad news is that the device, available in Europe since 2007, could have made it to American markets and saved more lives sooner if a risk-averse FDA hadn’t stood in the way.
In a must-read piece in City Journal Douglas Holtz-Eakin and Paul Howard detail how actions by the FDA and the Obama administration are harming both sick people and the American economy.
Cancer is such a deadly disease that the FDA often waives some trials but in the case of most illnesses you are going to have to wait a long time for innovative treatments:
The trials for new medicines that the agency requires—larger, longer, and more complicated than ever before—pose a serious threat to future innovation. In 1985, trials averaged about 1,700 patients; by 2005, that number had risen to 4,200.
The average drug’s clinical trials lasted just two and a half years in the 1960s, compared with nearly seven and a half years now. It can sometimes take even longer—ten or even 15 years—to bring a new drug to market today, and it can cost $1.3 billion.
The authors point out that this situation isn’t entirely the FDA’s fault—members of Congress are fond of hauling the FDA in for hearings if a drug develops an unforeseen side affect. Scapegoating the FDA may be good political theater, but ultimately it is bad medicine.
In addition, medical innovation in the U.S. is affected by our high corporate tax system—which makes it less expensive to build factories in other countries—and the tort system which means that unnecessary testing is done to protect, not patients, but vulnerable drug companies.
But you ain’t seen nothing yet:
The greatest threat to medical innovation is the Patient Protection and Affordable Care Act of 2010, often called Obamacare.
Companies can adapt to fickle regulators, high tax rates, greedy trial lawyers, and a small pool of potential employees, provided that they know, at the end of the day, that their products will reach the market and be paid for at fair prices.
But Obamacare’s newly created Independent Payment Advisory Board (IPAB) threatens the market incentives on which innovation relies.
IPAB, composed of 15 unelected experts, must make sure that Medicare spending doesn’t rise above a certain level. Because hospitals and other entities with political clout are exempted, IPAB will most likely end up cutting reimbursements for innovative treatments.
Note to people who got a heart valve: Be glad you got it now.
In a few years you'd probably be told to just take one of the red pills.