Maker of heroin antidote under fire

Federal and state officials are turning up the pressure on the manufacturer of an antidote to help treat heroin and prescription drug overdoses, as the price of the drug has soared in some areas by as much as 50 percent recently.

The drug, naloxone, has been around for decades and is traditionally used by first responders such as police officers and emergency medical technicians to reverse the effects of an overdose. In response to the price increases over the past few months, state attorney generals have pushed for the drug’s manufacturer, Amphastar, to offer rebates for public agencies that purchase the drugs.

The pressure comes as localities are dealing with soaring heroin and prescription drug overdoses over the past few years. The death rates for prescription drug overdoses quadrupled from 1999 to 2010, while the rates for heroin overdoses increased by more than 50 percent.

The death rate for heroin overdoses stands at every 2.1 people per 100,000 and 5.6 people every 100,000 for prescription drug overdoses, according to 2012 data from the Centers for Disease Control and Prevention.

As the overdose death rates have risen, so have prices for naloxone, especially over the past year. The drug is available in an injection and nasal spray.

Part of the problem is few manufacturers of the drug. A few drug makers produce the injectable version, but only Amphastar makes the spray version popular with law enforcement departments.

Another issue could be demand.

“Naloxone was administered to counter opioid overdoses an estimated 74,000 times in Ohio between 2003 and 2012, with more than 10,500 of those doses administered in 2012 alone,” said Ohio Attorney General Mike DeWine, who reached a deal with Amphastar to get a discount for the drug.

Amphastar President Jason Shandell told the New York Times last year that manufacturing costs have increased on an annual basis, but declined to comment further.

The drug can come in a kit that is used by law enforcement and first responders on overdose victims. The kit can cost about $60, and wholesale around $30.

Price increases have fluctuated throughout the country. In Georgia, for instance, the price of a kit rose from $22 to $40 recently, according to the nonprofit Phoenix House, which advocates on addiction issues.

New York police departments have seen a rise from $15 a dose last summer to $34.

New York Attorney General Eric Schneiderman reached a deal last week with Amphastar to cut and cap the price of naloxone. The drug maker will offer a $6 rebate per dose to the wholesale price, which will automatically increase dollar-for-dollar to match any future growth in the wholesale price, Schneiderman’s office said last week.

New York has disbursed more than 27,000 kits to law enforcement departments across the state in less than a year, Schneiderman said.

DeWine’s deal with Amphastar also will provide a $6 rebate for each naloxone syringe purchased by non-federal public entities in the state until March 2016.

Members of Congress also want to know how Amphastar came up with the price for the drug and why it jumped so high so quickly. Rep. Elijah Cummings, D-Md., and Sen. Bernie Sanders, I-Vt., wrote to Amphastar requesting detailed financial data such as total expenses related to the sales and production of the drug, and costs for marketing and purchasing active ingredients.

The two lawmakers are not strangers to the issue of prescription drug prices, having started an investigation and hearing last year on increases in generic drug prices. They even introduced legislation that would require drug makers to provide rebates for certain Medicaid and Medicare drugs.

While the drug is only primarily used by first responders, that could soon change. The Food and Drug Administration approved a version of naloxone that can be used by caregivers in case of an overdose.

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