Pharmaguy's Insights Into Drug Industry News
187.1K views | +30 today
Follow
Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
Curated by Pharma Guy
Your new post is loading...
Your new post is loading...
Scooped by Pharma Guy
Scoop.it!

FDA NexiumGate: Agency Delays Approval of Generic Version & Issuance of Stronger Warnings Of Brand

FDA NexiumGate: Agency Delays Approval of Generic Version & Issuance of Stronger Warnings Of Brand | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Will an FDA error mean that U.S. consumers will have to wait still longer to buy a generic version of the widely used Nexium heartburn pill?


Ranbaxy, you may recall, was the first generic drug maker to win the right to market a copycat version in the U.S., which would have allowed the company to do so for six months without any competition. The arrangement is designed to reward patent challenges to brand-name drugs and lower health-care costs.


But there has been a snag. The FDA banned imports of Ranbaxy products from four different facilities in India due to a raft of regulatory violations. And until manufacturing begins, the six-month market exclusivity remains in place, which means Ranbaxy rivals cannot make their own generic versions.


Last month, however, Ranbaxy executives confidently stated that they expected to be able to proceed with plans to sell generic versions of Nexium, which is marketed by AstraZeneca, and the Valcyte antiviral sold by Roche. Now, though, the FDA has rescinded the tentative approval, although the marketing applications remains under consideration, according to an agency spokeswoman.

What happened?

Pharma Guy's insight:


Not only did FDA's "mistake" cause a delay in a generic version of Nexium reaching the market, but the Agency also delayed issuing news safety warnings about the drug (see here). The result? All this helped AstraZeneca (AZ) post a healthy rise in third-quarter revenues as sales of the drug managed a small rise to $922m instead of a loss that would have occurred due to competition and bad safety news from the FDA (read Nexium windfall lifts AZ in third quarter).

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

FDA Takes 3 Years to Issue Stronger Warnings on Nexium, Prevacid, etc. & Only After Being Sued by Public Citizen

FDA Takes 3 Years to Issue Stronger Warnings on Nexium, Prevacid, etc. & Only After Being Sued by Public Citizen | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Note: On Friday, Oct. 31, the U.S. Food and Drug Administration both accepted and rejected portions of Public Citizen’s 2011 petition for stronger warnings on certain common antacid medications. It acted in response to a lawsuit filed by Public Citizen against the agency for unreasonably delaying action on the petition.

It now has been more than three years since the U.S. Food and Drug Administration (FDA) received our urgent 2011 petition for stronger warnings and patient medication guides on all proton pump inhibitor (PPI) products (such as Nexium, Prevacid, Prilosec, Protonix and several over-the-counter versions). It also has been six months since we sued the agency in federal District Court for unreasonable delay in responding to our petition. The FDA finally responded to our petition last Friday.

In its response (PDF), the FDA agreed with and granted the following requests:


  • “In the labeling of all PPI products, addition of information regarding the risk of Clostridium difficile-associated diarrhea and the risk of drug-drug interactions between PPIs and mycophenolate mofetil [anti-transplant rejection drug] and methotrexate [for rheumatoid arthritis and other conditions];
  • In the labeling of certain PPI products (omeprazole [Prilosec] and esomeprazole [Nexium]), addition of information regarding the risk of drug-drug interactions with clopidogrel [Plavix];
  • In the labeling of certain prescription PPI products, addition of information regarding the risks of vitamin B 12 deficiency and acute interstitial nephritis and certain information regarding treatment length for gastroesophageal reflux disease (GERD); and
  • Issuance of Medication Guides for certain prescription PPI products regarding certain safety risks.”


The approved uses for prescription PPIs include treatment of gastroesophageal reflux disease (GERD), erosive and ulcerative esophagitis, peptic ulcer and H. pylori eradication, pathological hypersecretory conditions, and upper-gastrointestinal bleeding prophylaxis in critically ill patients and those taking nonsteroidal, anti-inflammatory medications. However, PPIs are often prescribed for conditions they aren’t approved to treat. Many studies have found that the majority of people on PPIs were not prescribed them for an approved use.

The FDA’s rejection of our request for black box warnings on all these medications was misguided. The agency stated that three very serious conditions – C. difficile diarrhea, osteoporotic fractures and hypomagnesemia (low magnesium in the blood) – were not serious enough or occurred too infrequently to warrant such warnings. The agency also denied our request that several other warnings be added.

Although we are disappointed in the rejection of certain requests, the portions of the petition granted by the agency are important and will make the products safer. At the same time, it is unconscionable that the agency took more than three years to respond. The evidence for all of the warnings now granted was available more than three years ago, but the agency unreasonably delayed, endangering millions of patients.

In 2013, 130 million prescriptions were filled in the U.S. for these grossly overused products, which have evidence of serious adverse reactions, as we documented in our petition (PDF). The FDA delay, in addition to being unreasonable by the standards of the Administrative Procedures Act governing petitions to the government, has posed needless, avoidable, serious dangers to millions of patients in this country.

more...
No comment yet.