injections have been used to reduce the likelihood of premature births in at-risk pregnant women for years. Up until now, the drug was custom-compounded by wholesale and specialist pharmacies, legally, but without federal approval. These injections cost between $5 and $15 a dose and were regularly reimbursed by insurance companies and Medicaid.
Last month, the FDA announced their approval
of a commercially produced version of the compound, to be marketed under the brand name Makena by a company called KV Pharmaceuticals.
No stranger to controversy and trouble, KV barely survived a rash round of layoffs and wrongful termination lawsuits
. Their former chief executive now faces criminal charges
surrounding the company's failure to notify the FDA that they were producing oversized morphine tablets. (He could also do for a shave, it appears.)
Now, KV has announced that the new drug will be available at a cost of $1,500 per dose
, bringing the total pregnancy term cost of treatment to $25,000-$30,000
, from its former cost of $250-$300, a 100-fold increase
—but it gets worse... [more inside]
posted by disillusioned
on Mar 9, 2011 -
The US Food and Drug Administration
started regulating the labeling of food, beverages, and medicines after the passage of the 1906 Pure Food and Drug Act
, and added food coloring and cosmetics with the 1938 Food, Drug, and Cosmetic Act
. They have just released a new website, the FDA Notices of Judgment Collection, 1906-1963
, containing data from thousands of cases of mislabeled or misadvertised products and drugs, available in multiple forms (text, PDF, metadata XML, .TIF image, etc.), with searchable archives. Poking around in the data will yield information on cases ranging from misbranding methamphetamine tablets
, to quack "Film-O-Sonic" devices
, to bacteria-laden unproven abortifacients sold over the counter
, to purported "4-way" cures for baldness
, to hunks of radium sold for putting in your drinking water
to "stimulate the sex organs" (judged against for stating an unproven use, not for actual danger of product). Organized by the FDA's history office
, the new database is a fascinating resource for historians, public safety advocates, researchers, and librarians.
posted by Asparagirl
on Apr 6, 2009 -
[NewsFilter] A partial victory for public health over politics.
Amazingly, the FDA has finally, after 3 years of wrangling, approved over-the-counter sale of Plan B, an emergency contraceptive pill. The victory is partial because you need to be 18 or older to purchase it without a doctor's note. If you're under 18, you need to still have documentation from your physician (or nurse practitioner). The politics behind the approval process were laid bare in this (sincerely) fascinating GAO report
[note: links to .pdf file]. I also hope that OTC approval will avoid this
Plan B previously discussed on MeFi here.
posted by scblackman
on Aug 24, 2006 -