Novartis To Benefit from Its Own Drug Shortage?

Novartis To Benefit from Its Own Drug Shortage?

March 19th, 2012 // 3:35 pm @ jmpickett

Source: Pharmalot

Last month, Novartis slowed or discontinued production of various medicines at a plant in Boucherville, Quebec, where most of Canada’s generic injectables are made, after recent FDA inspections found various manufacturing problems (back story). And the move by the Sandoz facility has since created a shortage that has alarmed physicians and regulators alike.

Now, though, reports suggest that other Novartis facilities may actually benefit from the disruption. Of 23 applications from drugmakers that are seeking to ease the shortage of painkillers, sedatives and heart medicines, 15 are from Sandoz, Health Canada has told The Ottawa Citizen. The Novartis unit supplies roughly 90 percent of all injectables to hospitals in the country.

Whichever suppliers are chosen by Health Canada, prices are expected to rise. “The bottom line is, if we want these particular drugs, we’re going to have to pay more for them,” Michael Blanchard, clinical director of pharmacy services for HealthPro Canada, the country’s largest drug purchaser, tells the paper. Adds Doug Angus, a health economist at the University of Ottawa: The government is “probably going to have to make some very tough decisions about cutting other areas of health care in order to pay for the increased costs of those critical medications.”

Meanwhile, the federal government is upset that the drugmaker did not provide advance notice of the slowdown. Health Canada held discussions with Sandoz about the FDA warning letter from late November or early December through January, Steve Outhouse, director of communications for federal Health Minister Leona Aglukkaq, tells The Toronto Star.

“Their story kept changing,” Outhouse says, explaining that Sandoz at first said to expect a minor shutdown, which was later amended to a potential major shutdown and finally became a warning that a significant disruption was on the way, but medically necessary drugs would be protected. “They never gave us their plan.”

As a result, the federal government is considering mandatory reporting of shortages, he adds, although he notes such a system would not help in the event of a fire, which occurred at the Sandoz plant recently and temporarily suspended all production, or a notice to comply with FDA regulations. A spokesman for the Ontario Health Ministry tells the Star that “consequences” must be established for drugmakers that fail to supply the marketplace and/or give adequate notice of supply disruptions.”

Both the Canadian Generic Pharmaceutical Association and Canada’s Research-Based Pharmaceutical Companies late last week indicated they will work with the government to develop a nationwide strategy, but stopped short of saying they would support mandatory reporting, the paper notes (here is the statement).

The organizations say they would provide inventory tracking on a public, bilingual website, develop a system to report anticipated shortages and recommend solutions for unavailable medicines. All CGPA members already report current and anticipated shortages on public websites, a spokesman wrote the paper.