Home
Newsletter
Events
Blogs
Reports
Graphics
RSS
About Us
Support
Write for Us
Media Info
Advertising Info
Generic drugs

FDA delays generic drug guidelines that would save states millions

Friday, August 04, 2006 by: NewsTarget
Tags: generic drugs, health news, Natural News


Most Viewed Articles
https://www.naturalnews.com/019880_drug_FDA_the.html
Delicious
diaspora
Print
Email
Share

(NewsTarget) The Food and Drug Administration is withholding guidelines on the production of generic versions of insulin and human growth hormone (HGH) that would save states millions of dollars, prompting the governors of Kansas, Minnesota, Vermont and Wisconsin to petition the agency to move more quickly.

In their petition, the governors wrote that documents outlining what the FDA expected of drug makers before generic versions of the two drugs could be approved had existed since at least 2002, and that "there are no scientific reasons for delaying the issuance of the guidance documents FDA already has drafted."

In March, the FDA refused to issue guidelines specific to generic versions of the two drugs, opting instead to develop guidelines pertaining to generic biotech drugs -- drugs based on proteins from living cells, also known as biopharmaceuticals or biologics.

The governors said in their letter that HGH and insulin are different from biologics, and should not be lumped in with other biotech drugs. They added that both have relatively simple structures and have a long history of safe usage.

FDA spokeswoman Susan Bro disagreed that the case was not that simple. "These products raise complicated scientific issues and we continue to work on them internally," she said. "FDA will review the governors' concerns carefully and respond accordingly."

While the FDA approved Novartis A.G.'s Omnitrope -- a generic version of the growth hormone Genotropin, made by Pfizer Inc. -- in May, they were careful to label the knockoff a "follow-on protein product" rather than an actual substitute for Genotropin, and added that it "does not establish a pathway" for future approvals of similar products.

"This delaying tactic is yet another way the FDA protects the financial interests of Big Pharma," explained Mike Adams, an outspoken critic of the FDA. "Generic drugs reduce the profits of the industry's most powerful drug companies, and each day the FDA delays the introduction of generics to the market, Big Pharma earns millions more in profits," he said. "The FDA is engaged in widespread antitrust activities designed to protect the prescription drug monopoly market in the United States."

###


Receive Our Free Email Newsletter

Get independent news alerts on natural cures, food lab tests, cannabis medicine, science, robotics, drones, privacy and more.


comments powered by Disqus



Natural News Wire (Sponsored Content)

Science.News
Science News & Studies
Medicine.News
Medicine News and Information
Food.News
Food News & Studies
Health.News
Health News & Studies
Herbs.News
Herbs News & Information
Pollution.News
Pollution News & Studies
Cancer.News
Cancer News & Studies
Climate.News
Climate News & Studies
Survival.News
Survival News & Information
Gear.News
Gear News & Information
Glitch.News
News covering technology, stocks, hackers, and more