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Clinton announces plan to address 'unjustified' price hikes on life-saving drugs

[September 02, 2016] By Amanda Becker

WASHINGTON (Reuters) - Hillary Clinton said on Friday that if elected to the White House, she would create an oversight panel to protect U.S. consumers from price hikes on life-saving 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," including the ability to levy fines and impose penalties on manufacturers when there has been an "unjustified, outlier price increase" on a long-available drug, her campaign said.

"Over the past year, we've seen far too many examples of drug companies raising prices excessively for long-standing, life-saving treatments with little or no new innovation or R&D," Clinton said in a statement.

If Clinton defeats Republican Donald Trump in the Nov. 8 election, she will need the support of the U.S. Congress to implement key measures she has proposed, such as levying fines on manufacturers responsible for unjustified price hikes.

Lawmakers have in the past resisted efforts to introduce controls on pharmaceutical prices.

But Clinton's campaign cited Turing Pharmaceuticals LLC raising the price of the AIDS drug pyrimethamine and Mylan’s <MYL.O> 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.

Drugmakers have insisted that lowering or limiting drug prices will 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 “sub category” 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.

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Democratic presidential nominee Hillary Clinton addresses the National Convention of the American Legion in Cincinnati, Ohio, U.S., August 31, 2016. REUTERS/Bryan Woolston

'BOLD IDEA'

The oversight panel would be made up of representatives from existing public health and consumer protection agencies who 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 United States.

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 U.S. Food and Drug Administration. Although the time line has shortened, there is often not enough consistent demand for manufacturers to enter the U.S. 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 spoke to Clinton’s campaign about his research as it developed its proposals.

(Reporting by Amanda Becker; Editing by Peter Cooney)

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