Feds Seize Unapproved Drugs From KV Pharma
2 CommentsBy Ed Silverman // July 29th, 2008 // 6:50 pm
Agents from the FDA and the US Marshal’s Service grabbed $24.2 million worth of unapproved drugs from the specialty drugmaker’s facilities, The St. Louis Business Journal reports. The majority of the products seized were made after the FDA required an end to their production, according to US Attorney Catherine Hanaway (see statement).
The seizure followed an FDA inspection of several of KV’s plants earlier this year, when investigators found the drugmaker was not complying with an FDA enforcement notice warning that drugs in time-release format containing guaifenesin, an expectorant, must be approved by the FDA to ensure the safe and effective release of the active ingredients.
Unapproved meds are becoming a hot topic. The US Senate Finance Committee recently began looking into the problem as part of an investigation into Medicaid drug reimbursements. And one Maryland drugmaker was recently barred from manufacturing and distributing prescription meds until its operations are brought into compliance and FDA approval is obtained for its products.
The FDA required KV to stop manufacturing the affected products before August 27, 2007, and to stop shipping the products before November 26, 2007. KV, however, continued to make and distribute the unapproved drugs, but now says it will dispose of its inventory of cough and cold meds or have federal agents get rid of them. Here is the forfeiture complaint.
But the inspectors also found the company was manufacturing and distributing other unapproved new drugs such as products for cough, cold, topical wound healing, skin bleaching and gastrointestinal conditions.
“The FDA will take action against companies that continue to manufacture or market an unapproved product after the marketing or distribution cessation date,” Deborah Autor, director of the FDA’s Office of Compliance in the Center for Drug Evaluation and Research, says in a statement.
The following drug products were seized: PhenaVent capsules, PhenaVent LA capsules, PhenaVent PED capsules, Ethezyme Papain-Urea ointment, Ethezyme 650 Papain-Urea ointment, Ethezyme 830 Papain-Urea ointment, Hista-Vent DA tablets, Meperidine/Promethazine capsules, Pseudovent capsules, Pseudovent 400 capsules, Pseudovent PED capsules, Tri-Vent DM syrup, Tri-Vent DPC syrup, Hydro-Tussin DM liquid, Hydro-Tussin CBX syrup, Hydro-Tussin DHC syrup, Hydro-Tussin EXP syrup, Hydro-Tussin HD syrup, Hyoscyamine Sulfate Sublingual tablets, Hydroquinone 4 percent cream, Hydroquinone 4 percent cream with sunscreen, Bromfenex extended release capsules and Bromfenex PD extended release capsules.
Dan A.
Thanks for writing this, and the results of the intervention.
KV is not alone regarding the marketing of unapproved drugs. One example is http://www.aurigalabs.com.
The conspirators are typically venture capitalists who discover that all that is needed to sell thier bogus prescription medications is to simply obtain what is known as an NDC number for each product. This number is necessary for wholesalers to purchase such fradulent prescription drugs, who then sell them to pharmacists. With the exception of the criminals, all others simply surmise or presume that these potentially dangerous prescription medications have been FDA approved. The criminal guards appear confident that the prison guard is asleep (The FDA) and therefore their actions are tacitly approved, so it seems. The website I shared with you was in fact involved in this activity, and the Auriga CEO was an ex FDA Lawyer named Phil Pesin.
There are probably more such companies allowing potentially unsafe drugs to be acquired by U.S. Citizens. My suggestion is that, just because a medication can be obtained by a pharmacy, does not mean it has been evaluated or approved. A similar stance should possibly be taken with prescription drugs acquired over the internet.
Dan Abshear
Phone: 636-639-1027
Diane
It’s too bad that everyone cann’t work together on this. This medication was really helping me breathe better. Now I am miserable and find it very hard to breathe. I cann’t sleep for more than a few hours because either I am having a difficult time breathing or I am choking on the mucous. I was taking pseudovent 400.