- Thomson Reuters
Hillary Clinton said on Friday that if elected to the White House, she would create an oversight panel to protect US consumers from price hikes on lifesaving drugs and import alternative treatments if necessary.
Clinton, the Democratic presidential nominee, will seek to give the panel an “aggressive new set of enforcement tools.”
The panel, made up of representatives from existing public health and consumer protection agencies, would have the ability to call out drugs that have either increased in price dramatically, have a high price relative to how much the drug costs to make, or don’t have a price that makes sense relative to the value it’s bringing to patients.
According to a fact sheet released Friday, the panel would be able to:
- Make alternative drugs available by supporting manufacturers that make competing drugs and finding ways to drive up competition while bringing down the prices of the drugs. Import drugs from other countries with similar safety standards to the US in emergency situations. Place penalties, including fines, on drugmakers. That money could then be used to increase access to the drug.
“Over the past year, we’ve seen far too many examples of drug companies raising prices excessively for long-standing, lifesaving treatments with little or no new innovation or R&D,” Clinton said in a statement. “It’s time to move beyond talking about these price hikes and start acting to address them. All Americans deserve full access to the medications they need – without being burdened by excessive, unjustified costs. “
If Clinton defeats Republican nominee Donald Trump in the November 8 election, she will need the support of the Congress to implement key measures she has proposed, such as levying fines on manufacturers responsible for unjustified price hikes.
Lawmakers have resisted efforts to introduce controls on pharmaceutical prices.
But Clinton’s campaign cited Turing Pharmaceuticals raising the price of Daraprim, its AIDS drug, and Mylan’s recent move to increase the cost of EpiPen for severe allergy sufferers as “troubling” examples of price hikes that have attracted scrutiny from Republican lawmakers as well as Democrats.
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Drugmakers have insisted that lowering or limiting drug prices would hamper their ability to invest in research and lead to fewer new therapies.
Dr. Peter Bach, the director of a nonpartisan health policy research group at New York’s Memorial Sloan Kettering, said Clinton’s announcement was a “flag” for drug manufacturers that her administration would notice and respond to steep price hikes.
“It’s a response to the broader industry phenomenon of generating added profits by raising the price of drugs for which there is no competition,” Bach said, saying the campaign was focusing on a “subcategory” of manufacturers that had not invested heavily in developing the drug.
Bach said he was contacted by the Clinton campaign about his work on drug pricing but had not advised the campaign in a formal capacity.
The oversight panel would convene to examine the scope of a drug increase, the manufacturer’s production cost, and the treatment’s relative value to patients and public health, Clinton’s campaign said.
In cases where a determined unjustified price hike is accompanied by insufficient market competition, Clinton’s administration would intervene to purchase alternative drugs from comparably regulated markets or assist manufacturers in bringing the product to market in the US.
Dr. Aaron Kesselheim, an associate professor at Harvard Medical School, called it a “bold idea” to get the federal government “involved in helping stabilizing some of these generic drug markets.”
Until recently, there was a lengthy wait for generic drug approval by the Food and Drug Administration. Although the timeline has shortened, there is often not enough consistent demand for manufacturers to enter the US market, Kesselheim said.
“Having the government get involved as a long-term purchaser of these products creates a stockpile to stabilize the market,” Kesselheim said.
Kesselheim has testified before Congress about high-cost generic and long available drugs, and he spoke to Clinton’s campaign about his research as it developed its proposals.
(Reuters reporting by Amanda Becker; editing by Peter Cooney)