Valsartan Recall a Money-Maker for Some Generic Drug Manufacturers

Published on February 7, 2019 by Sandy Liebhard

While many generic drug makers were hit hard by last year’s valsartan recall, it seems some were actually able to profit from the debacle.

Aembic Pharmaceuticals, for example, used the “one-off opportunity” to triple prices on 17  valsartan products, with increases ranging from 329% to 469%.

“So, we could respond very fast to the valsartan opportunity and we could ramp up our supplies and we could get on the market at a high price and that is what is sold,” Pranav Amin, Alembic’s managing director, said during a conference call with analyst and investors last October.

According to The Wall Street Journal, prices for  McCleods Pharmaceuticals’s valsartan products increased by as much as  305%.

Price-Gouging After Valsartan Recall Hit Uninsured Hardest

The price-gouging likely went unnoticed by consumers with prescription drug coverage. However, they could see their co-pays and premiums rise next year, as insurance companies respond to the price increases.

And of course, the price hikes dealt a significant blow to those without coverage. When patients can’t afford their medications, some will put their health at risk by rationing their drugs or foregoing treatment altogether.

“How do you convince them from a public health perspective to do the right thing?” Peter J. Pitts, president of Center for Medicine in the Public Interest, asked during an interview with USAToday. “I don’t believe any company that makes any drug, whether it is an innovative biotech cancer drug or a generic drug that’s been around for 50 years, should take advantage of the marketplace to a degree that causes significant financial pain for patients.”

What the Valsartan Recall Means for Patients

Alembic and MaCleods were among the few generic drug makers unaffected by last year’s  valsartan recall, which was triggered by the discovery of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) in active pharmaceutical ingredients manufactured by two overseas suppliers.

Both compounds are considered probable human carcinogens. As a result, numerous generic drug makers around the world, including Mylan Pharmaceuticals, Teva Pharmaceuticals, Sandoz, Prinston Pharmaceuticals, ScieGen, and Torrent Pharmaceutical, pulled valsartan products off the market.

Eventually, the recall expanded to include the following angiotensin II receptor blockers (ARBs):

  • Single-ingredient valsartan
  • Amlodipine in combination with valsartan
  • Valsartan HCTZ
  • Single-ingredient irbesartan
  • Irbesartan HCTZ
  • Single-ingredient losartan
  • Amlodipine in combination with losartan
  • Losartan HCTZ

Consumers taking any of the above medications should contact their pharmacy to determine if their drug is under recall. They can also check regularly-updated lists of recalled  valsartan products losartan medications, and irbesartan products  posted on the FDA’s website.

Those with a recalled medication should continue to take the drug until they obtain a replacement from their doctor or pharmacy. Patients who suddenly stop taking an ARB could experience dangerous blood pressure spikes and other life-threatening health consequences.

Valsartan Lawsuit Plaintiffs Await Decision

Dozens of people throughout the United States have already filed valsartan lawsuits seeking compensation for cancer allegedly caused by tainted ARBs.

Last week, the U.S. Judicial Panel on Multidistrict Litigation heard oral arguments on a motion to centralize product liability claims associated with the valsartan recall in a single federal court for coordinated discovery and other pretrial proceedings. The panel could issue its decision on the motion any day now.

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