Orphan drug designation?
I have a very good friend who has spent his life in helping people. They had a drug this year they could compound for $25 with FDA approval and it helped mothers and their unborn child. Now in sweeps a new company and now the pharmacies have been severed with notice to stop producing the medications. This new company is selling the same product....for $1,500 per dose. This requires mulit doses and the women at the most risk usually don't have insurance...so who will pay?
The Food and Drug Administration (FDA) has determined that DELALUTIN (hydroxyprogesterone caproate) injection, 125 milligrams (mg)/milliliter (mL) and 250 mg/mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for hydroxyprogesterone caproate injection, 125 mg/mL and 250 mg/mL, if all other legal and regulatory requirements are met. However, in considering whether to file an ANDA for hydroxyprogesterone caproate, future applicants are advised that they may not be able to obtain DELALUTIN (hydroxyprogesterone caproate) injection, 125 mg/mL and 250 mg/mL, for bioequivalence testing because the product has not been commercially available for a number of years. An ANDA applicant who is unable to obtain DELALUTIN (hydroxyprogesterone caproate) injection, 125 mg/mL and 250 mg/mL, for bioequivalence testing should contact the Office of Generic Drugs for a determination of what is necessary to show bioavailability and same therapeutic effect..
Supplementary information:
In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the "listed drug," which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug.
Now if that's not enough............
File this under 'if something can go wrong, it will.' KV Pharmaceutical was tagged last year by the FDA for making and selling unadulterated and unapproved drugs (see here). Since then, manufacturing has been idle for 15 months, KV is short of cash, and 289 people - or about three-quarters of its workforce - was just let go.
Meanwhile, David Hermelin, a former vp of corporate strategy and operations, filed a charge of religious discrimination against KV last September. KV denies his dismissal was tied to religion. Hermelin is the son of Marc Hermelin, KV's former chairman and ceo, who was dismissed in December 2008 amid a probe into alleged mismanagement, The St. Louis Business Journal writes. However, Marc Hermelin claims he retired from his position prior to his termination by the board. At stake in the dispute is $10.8 million in accrued retirement benefits. Both David Hermelin and Marc Hermelin are still members of KV's board, because they hold 62 percent of the voting power of two classes of common stock.
And last month, a wholly owned subsidiary known as Ethex pleaded guilty to two felony counts of criminal fraud for failing to report to the FDA that it was making oversize tablets that could be harmful to patients, The St. Louis Post-Dispatch notes. A KV exec considered what to do in July 2008 after KV discovered oversize tablets and oOne option was "to do nothing because the probability of oversized tablets is very low," Assistant US Attorney Andrew Lay said in court papers. Over the objections of other employees, the executive chose the "do-nothing option." The unnamed exec instructed multiple employees to "minimize written communications about KV's oversized tablet manufacturing problems and limit distribution and discussion of any documents discussing these problems," according to the prosecutor.
"Bottom line is you just don't mess with the FDA, and this has happened again and again at KV," Juli Niemann, an analyst at Smith, Moore & Co., tells the Post-Dispatch. "Trying to take shortcuts for profitability is a systemic problem there." Adds Lawrence Solow, an analyst at CJS Securities: "It's a disaster."
"It's a disaster," said Lawrence Solow, an analyst at CJS Securities, a New York brokerage and research firm. "If within six months they don't start generating revenues, they may end up in bankruptcy."
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