Starting in late 2015, there has been growing public outrage over drug price increases, culminating so far with executives from Turing Pharmaceuticals and Mylan being grilled during congressional hearings over possible price gouging. Type 1 diabetes advocates have wondered aloud when that public anger might turn toward insulin prices, as the price of most insulins has risen by more than 500 percent since 2001.
Congressional hearings are one thing and legislative action is another, but the issue of drug pricing has become an important talking point of the presidential election. In past presidential elections, advocating for even modest government control of drug pricing would have been enough to bring poll numbers down. This year, both major candidates, Hillary Clinton and Donald Trump, have spoken of plans to force drug companies to lower drug prices. While neither candidate has focused on insulin, their policies, if implemented, could put downward pressure on insulin pricing.
Of the two, Clinton has made drug price control more of a central issue in her campaign (although it should be said that neither candidate has put the issue on the front burner). For this article, we will focus on her proposal, and what it’s chances are of creating reform.
Here are some highlights of her plan, focusing on what might have the greatest impact to lower the price-tag on insulin:
- A $250 cap on monthly out-of-pocket expenses for prescription drug costs.
- A ban on “pay-for-delay” arrangements between drug companies that would keep competing generic drugs off the market for a period of time (Sanofi made a deal like this with Lilly to shelve a biosimilar version of Lantus).
- Creation of a regulatory group that watches for unreasonable increases in drug prices and penalizes companies found to be price-gouging.
- Increased access to generic versions of existing drugs by streamlining the FDA process for reviewing generics and by allowing emergency importation of generics (Mr. Trump also has discussed importation of drugs to lower drug prices).
- Allowing Medicare officials to negotiate prices with drug companies (Trump has talked up this proposal more than Clinton).
If these five points were enacted, it certainly seems like Clinton’s plan would put significant downward pressure on insulin pricing and cap the amount individuals would have to spend on insulin. The key word here is “if”. Most of these proposals would require new legislation, and that takes the cooperation of Congress.
Many political observers currently believe that a President Clinton would face a divided or hostile Congress, with either the House of Representatives or both the House and the Senate in Republican hands. If Republicans in Congress and a President Clinton find as little opportunity for bipartisanship as Republicans and President Obama have, the chances for legislative action to enact these policies would be low.
Partisan tactics wouldn’t be the only hurdle she would face to get Congress to take action. According to a U.S. News and World Report article, the trade group representing the pharmaceutical industry spent $18 million lobbying Congress, both Democrats and Republicans, in 2015. Legislation similar to parts of Clinton’s plan have been proposed in Congress this past year, only to die on the vine.
There is one longshot to this gridlock, however: Congress may already have authorized some governmental price control in 1980 with the passage of the Bayh-Dole Act, according to a L.A. Times report. This law says, among other things, that if a drug was developed either partly or wholly with government funds, it must be made available to U.S. consumers at a reasonable price. Frankly, I have no idea whether any of the current insulin formulations on the market were developed with government funds. If they were, you would still have a legal argument on your hands about what a “reasonable price” is.
In the end, a President Clinton, or a President Trump, is going to need the help of Congress to get these reforms passed. The only way Congress will take action is if it feels steady, concerted pressure from voters. For Type 1 diabetes advocates, that will mean paying attention to local congressional elections as much as the presidential election, and continuing to call attention to the issue of insulin prices long after November 8th has passed.
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