Democratic Platform Silent on FDA Reforms; Eyes Drug Costs
The 2016 Democratic Party Platform released in advance of this week’s convention in Philadelphia is silent on FDA and any reform ideas. This is in sharp contrast to last week’s GOP Platform 2016 document that highly criticized the agency and pledged reforms (see story).
Despite the absence of any FDA reforms, the Democratic platform does take aim at healthcare and drug prices, among other issues. “Democrats will keep costs down by making premiums more affordable, reducing out-of-pocket expenses, and capping prescription drug costs,” it says. “It is unacceptable that the United States pays, by far, the highest prices in the world for prescription drugs and that too many Americans between the ages of 18 and 64 cannot afford to fill their prescriptions. A lifesaving drug is no good if it is unaffordable to the very people who need it most. And many drug companies are spending more on advertising than on research. The largest pharmaceutical companies are making billions of dollars per year in profits at higher margins compared to other industries while many stash their profits in offshore tax havens.”
Democrats say they are committed to investing in the research, development, and innovation that creates lifesaving drugs and lowers overall health costs, “but the profiteering of pharmaceutical companies is simply unacceptable. We will crack down on price gouging by drug companies and cap the amount Americans have to pay out-of-pocket every month on prescription drugs. We will prohibit anti-competitive ‘pay for delay’ deals that keep generic drugs off the market, and we will allow individuals, pharmacists, and wholesalers to import prescription drugs from licensed pharmacies in Canada and other countries with appropriate safety protections. Democrats will also fight to make sure that Medicare will negotiate lower prices with drug manufacturers.”
Additionally, Democrats support additional investments in cutting-edge medical research. “Democrats believe we must accelerate the pace of medical progress, ensuring that we invest more in our scientists and give them the resources they need to invigorate our fundamental studies in the life sciences in a growing, stable, and predictable way,” the platform says. “We must make progress against the full range of diseases, including Alzheimer’s, HIV and AIDS, cancer, and other diseases, especially chronic ones. We recognize the critical importance of a fully-funded National Institutes of Health to accelerate the pace of medical progress.”
The Republican platform, on the other hand, charged that FDA is now threatening “America’s leadership in life sciences R&D and medical innovation” through a “lack of predictability, consistency, transparency and efficiency … that is driving innovation overseas, benefiting foreign, not U.S., patients.” It said that FDA “has slowly but relentlessly changed into an agency that more and more puts the public health at risk by delaying, chilling, and killing the development of new devices, drugs and biologics that can promote our lives and our health.” It calls for leadership “that can reform the agency for our century and fix the lack of predictability, consistency, transparency and efficiency at the agency. The FDA needs to return to its traditional emphasis on hard science and approving new breakthrough medicines, rather than divert its attention and consume its resources trying to overregulate electronic health records or vaping.”