The FDA has fast-tracked the approval of a generic version of valsartan while looking at the drug’s manufacturing process.
Wave after wave of a medication used to treat high blood pressure and congestive heart failure has been recalled over the past 12 months after being found to contain trace amounts of potentially dangerous impurities.
“We know that the ongoing recalls to prevent certain lots of valsartan that contain unacceptable limits of impurities from reaching patients has resulted in a shortage of these important medicines,” FDA commissioner Dr. Scott Gottlieb, said in a press release.
“So to address the public health consequences of these shortages, we’ve prioritized the review of generic applications for these valsartan products.”
Hundreds of lots of the drug made by different manufacturers have been voluntarily recalled by various companies since late July after being found to contains traces of known carcinogens, including:
- N-nitrosodiethylamine (NDEA)
- N-nitrosodimethylamine (NDMA)
- N-methyl nitroso butyric acid (NMBA)
“We hope that today’s approval of this new generic will help reduce the valsartan shortage, and we remain committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes for existing and future products,” Gottlieb said.
In short, this new FDA approval (granted to Alkem Laboratories Limited) is likely to be the first of several, as the agency scrambles to facilitate an adequate and continuous supply of safe blood pressure drugs.
The new drug approval comes after the federal agency says it identified the cause of these impurities in the manufacturing process.
The agency also says it’s started to put new requirements into place to prevent the risk of this contamination from recurring, noting “systemic problems of supervision that could have created the conditions for quality issues to arise.”
One of those systemic problems may have to do with how pharmaceutical companies acquire the active pharmaceutical ingredients (APIs) for the medications they sell, Dr. David Belk, a board-certified doctor of internal medicine and founder of consumer advocacy website The True Cost of Healthcare, told Healthline.
Often, one or a handful of large manufacturers create large quantities of the active ingredient of a drug, which is then bought by different pharmaceutical companies to formulate with their inactive ingredients.
The problem, he said, is that “there is very little oversight for the manufacturing of the APIs or where pharmaceutical companies can purchase them. Only the final product is evaluated by the FDA.”
That means a mishap at a single manufacturer can have an outsized effect on an entire industry.
“It’s the snafus in API production that have caused most of the recent shortages and recalls of generic drugs in this country,” Belk said. “The FDA should probably look into that process a bit more closely.”
For its part, the FDA says that it’s confident this newly approved generic valsartan is free of the impurities that caused the previous recalls.
“[We] evaluated the company’s manufacturing processes and also made sure they used appropriate testing methods to demonstrate that the valsartan product approved today does not contain NDMA or NDEA,” agency officials said.
“The FDA’s assessment of the manufacturing processes for the product determined that there is no known risk for the formation of other nitrosamine impurities.”
The FDA released new guidance in 2018 to manufacturers for limiting these carcinogens in valsartan manufacturing.
Moreoever, since the wave of recalls began, FDA “scientists have developed and refined novel and sophisticated testing methods specifically designed to detect and quantify the NDMA and NDEA,” the agency said in a January 2018 statement.