Drug Pricing Debates Get Politicized in the wrong way

This week Presidential contender Senator Bernie Sanders announced that he would block Dr. Robert Califf’s nomination to lead FDA due to his “lack of commitment to lowering drug prices”. Doing this he joins Senator Markey who opposed Califf for approving opiates, and Senator Murkowski who is opposed due to labeling of genetically modified salmon. However, Mr. Sander’s opposition seems to be the most egregious. Mr. Sanders wants Dr. Califf to “work towards substantially lower drug prices, implement rules to safely import brand-name drugs from Canada and hold companies accountable who defraud our government”. However, there are already laws to hold companies accountable when they defraud the government. Allowing imports from Canada in principle makes FDA responsible for the quality of drugs sold in Canada. There are obvious concerns about the quality of drugs imported due to risk of counterfeit and sub-standard drugs. And FDA is not allowed under the law to regulate drug pricing. FDA commissioner has no say in how a company assigns the list price of its drug. Hence, a FDA commissioner cannot “commit” to lowering prices of drugs under conditions proposed by Mr. Sanders. The struggle to control price of prescription drugs is certainly a worthy fight. There are many examples of drug prices being unreasonably high. The issue was brought to the front pages last year by Turin Pharma increasing price of a very old drug by 5000%. But that case was just a highlight of the wide-spread price gauging in the industry. There is great public support for finding ways to regulate drug prices. Turin was countered by a compounding pharmacy making potentially illegal copies of their drug. Some good ideas have been proposed to address the drug price in a multi-dimensional manner. However, unreasonable demands could lead to lost opportunity to create new laws to manage price of prescription drugs. This discussion will bleed into the price of biotech products, where the prices are even higher. FDA this week announced plans to create a path to interchangeable biosimilars.  Biosimilars that can replace innovator biologics can dent the price of these expensive biotech products. The first biosimilar approved by FDA is sold at a 15% discount over the biologic that it is similar to. The same, if interchangeable, could lead to further discounts. We are on the cusp of a reasonable agreement with industry to regulate prescription drug prices with universal political and public support to reign in prices. The issue needs to be politicized to keep the momentum. However, this opportunity could easily slip by if politicians try to make unreasonable demands from any of the stakeholders.