Jordan Reimschisel joins the podcast today to talk about his recent piece in RealClearHealth regarding the FDA and slowing medical innovation. He argues that the process of the FDA is based off a warped incentive structure that places excessive caution ahead of innovation that could save lives.
Last week, the Senate Committee on Health, Education, Labor, and Pensions met to consider legislation that would reauthorize the Food and Drug Administration’s (FDA) user fee programs. These programs make up a large part of the agency’s budget. This process will continue over the next several weeks.
Earlier this month, the House Committee on Energy and Commerce also held a hearing to consider improvements to the regulation of medical technologies. This will most likely become a part of the reauthorization legislation. While an admirable goal, the true goal that policy makers should pursue is to create an environment in which innovation and entrepreneurship can thrive with as few barriers as possible.
Since the legalization of same-sex marriage throughout the United States, many gay individuals and allies seem to believe that the government has granted full legal equality. Sadly, this is not truly the case, and the fine print of the recent overturn of a 30-year FDA blood ban from gay and bisexual men truly shows how our system continues to act against LGBT Americans.
The blood ban was not removed. The FDA merely changed it from a lifetime ban to a requirement that a potential donor abstain from sex with another male for an entire year. This might seem like an advancement for equality, but in reality it’s a mere reconstruction of a discriminatory policy promoting HIV stigma, and reinforcing the belief that AIDS is a “gay” disease.
The FDA blood ban was first enacted during the initial breakout of the disease as a measure to prevent spreading the virus, but since then the law has become outdated primarily due to new technology. According to the FDA, testing of donated blood has reduced HIV transmission through donated blood from 1 in 2500 to 1 in 1.47 million. With such great progress HIV screening, the restrictions on men who have had sex with men is not only discriminatory but also highly unscientific.
Contrary to the popular belief that the U.S. Food and Drug Administration (FDA) protects American consumers from dangerous drugs produced by malicious drug companies, FDA drug regulations actually benefit big pharma. And this benefit occurs by increasing the cost of prescription drugs for the poorest Americans. We can see this injustice in the recent EpiPen controversy.
The drug company Mylan recently announced that they were increasing the price of their drug known as the EpiPen by nearly 500 percent since 2007. The EpiPen is a device that allows someone suffering from potentially fatal allergy symptoms to inject epinephrine into their system, reducing the symptoms and possibly saving their life. Since the drug is widely used and so important for many people, the price increase ignited a political and media firestorm. Pundits from bothsides of the aisle are outraged, saying that the company should be forced to lower the price.
But the drug company is not the only organization at fault. Like any other corporation, Mylan is in business to make money. The FDA, on the other hand, whose official vision is that “public health is advanced and protected,” goes against this mission every day.
Most people agree minors should not have access to products that contain substantial levels of nicotine (and “substantial” is used because many foods contain trace amounts of nicotine). But, in focusing on this move, commentators are missing how the FDA’s new regulations will destroy 99 percent of an industry that offers an option the Royal College of Physicians finds is 95 percent safer than cigarettes.
The FDA’s regulations will force all e-cigarette products to go through the costly and time-consuming premarket tobacco product application process, a step that all but the big tobacco companies will not be able to comply with.