All these stories about drug shortages seem to just nibble around the edges. It says the US drug maker can no longer produce the drug because the active ingredient is not available in the US, and US authorities are reluctant to allow the ingredient to be imported.
They don’t say who supplied the active ingredient previously, why it is no longer available, why it would have to be imported and why the imports are not allowed.
Shoddy reporting by very un-curious reporters. And it seems to be the same in other stories about drug shortages: no explanation about why there are now shortages where there were none previously.
I think Shoddy Reporting is part of the core curriculum in J-school. Somewhere along the line someone stopped telling the students it was a review of what NOT to do.
“All these stories about drug shortages seem to just nibble around the edges.”
Because this problem can be laid SQUARELY at the feet of OBAMA, and government regulation. WHO KNEW....
From the National Center for Policy Analysis:
A drug manufacturer must get approval for how much of a drug it plans to produce, as well as the timeframe. If a shortage develops (because, say, the FDA shuts down a competitor’s plant), a drug manufacturer cannot increase its output of that drug without another round of approvals. Nor can it alter its timetable production (producing a shortage drug earlier than planned) without FDA approval.
Even the Drug Enforcement Agency (DEA) has a role — because minute quantities of controlled substances are often used to make other drugs. This is the apparent reason for a nationwide shortage of ADHD drugs, for example, including the generic version of Ritalin. And like the FDA, DEA regulations are rigid and inflexible. For example, if a shortage develops and the manufacturers have reached their preauthorized production cap, a manufacturer cannot respond by increasing output without going back to the DEA for approval.
The Centers for Medicare and Medicaid Services (CMS) also has a role – levying large fines for “overcharging,” forcing some companies to leave the generic market altogether.
Price Controls. Also contributing to the problems of many facilities is a little known program that forces drug manufacturers to give discounts to certain end users. The federal 340B drug rebate program was created in 1992 to provide discounted drugs to hospitals and clinics that treat a high number of indigent patients, clinics treating patients on Medicaid, hospitals and clinics in the Public Health Service and certain Federally Qualified Health Centers (more listed here). Currently, the law requires drug companies to provide rebates of 23.1 percent for brand drugs; and 13 percent for generic drugs off of their average manufacturer’s price on qualifying outpatient drug use. States have the right to negotiate further discounts and actual rebates negotiated are typically much steeper than the federal requirement.
This state of affairs did not start with the Affordable Care Act (ObamaCare). By expanding the number of hospitals and clinics that are allowed to participate in the program, however, the Affordable Care Act will make things worse. In 2002, about 8,000 hospitals and clinics were in the program. By 2010 more than 14,457 were participating. The total number of eligible hospitals and clinics is now estimated at nearly 20,000.
Economics teaches that when prices are kept artificially low, shortages develop. People cannot get all of the care they try to obtain at the existing rate. Also, regardless of the apparently multiple causes of the shortages, certain patterns tend to emerge. People respond to persistent shortages by doing things that invariably make the problem worse.
My googling failed to turn up the reason for the shortage, other than some unspecified problem that caused the old manufacturer of the active ingredient (melarsomine dihydrochloride) to stop making it, and the drug company scrambling to find a another domestic manufacturer to make it (the FDA is disallowing foreign suppliers, for whatever reason).
Since melarsomine dihydrochloride contains arsenic, I suspect the EPA had something to do with the old manufacturer getting out of the business. Reporters in the current climate seem reluctant to trace problems back to the Obama administration's own policies.
I do not understand why we don’t know why we have shortages of certain drugs. This makes no sense, and you’re right, why is the media not on this story like white on rice?