FDA guilty of malfeasance
Can the Food and Drug Administration be charged with malfeasance in office?
I have a complaint that I have found is not unique. Others have had the same problem with other prescriptions.
A foot injury many years ago has left me subject to attacks of gout. I have been taking a daily maintenance dose of colchicine that is now suddenly not available.
A drug known since ancient times, it was grandfathered in when the FDA established its list of approved drugs.
Recently a pharmaceutical company discovered that it had never had the testing to be listed as “certified.” Apparently there are a number of these drugs that are being claimed by these opportunistic drug companies.
In return for doing the testing on this drug, already in use for centuries, the company was granted a patent by the FDA and no one can market it. The company has given it a new name and put it back on the market.
My problem? The drug that I have been getting for years at $10 for a three months supply will now cost $170 a month.
You can understand my outrage.
Who paid off whom?
My answer for the moment is to hoard the small amount I have on hand, stop taking this drug and hope the gout does not return.
Teva Warns, and Merck and Glaxo Post Losses
One of the world’s largest generic drug makers disclosed Thursday that the Food and Drug Administration had sent it a warning letter over manufacturing problems.
Separately,two major pharmaceutical companies reported fourth-quarter losses Thursday, hurt by one-time charges for product setbacks.
Teva Pharmaceutical Industries, the Israeli generics company that is the largest supplier of prescription drugs in the United States, disclosed in a government filing that the F.D.A. had warned it about manufacturing problems at a plant in Jerusalem.
The F.D.A. warning says Teva failed to adequately investigate impurities in the diabetes medicine glyburide metformin (generic Glucovance), product specification errors in the sleep pill zolpidem tartrate (generic Ambien) and cross-contamination issues.
“Without proper separation, your firm lacks assurance that one drug does not contaminate another drug,” Richard L. Friedman, director of the F.D.A. division of drug manufacturing and product quality, wrote in the letter, released by Teva.
The company said it received the warning letter Jan. 31 after responding last October to an F.D.A. inspection in September. The company said it was working diligently to solve the problems.
Mr. Friedman wrote that Teva could be barred from exporting products from the Jerusalem Oral Solid Dosage facility to the United States if the problems are not corrected. The F.D.A. had no immediate further comment.
Analysts say the facility accounts for less than 3 percent of the products from Teva, which has about $16 billion annual sales. Teva reports fourth quarter earnings next week.
Meanwhile, special charges wiped out fourth-quarter profits for GlaxoSmithKline and Merck.
GlaxoSmithKline, which is based in London, took a $3.5 billion charge to settle litigation over the diabetes pill Avandia. The drug was banned in Europe and severely limited in the United States last year because of heart risks.
Merck took a $1.7 billion charge to write down a suspended clinical trial on an experimental blood thinner, vorapaxar, once considered the best prospect from the company’s $49 billion purchase of Schering-Plough.in 2009.
Merck’s 2011 forecast also fell short of analyst estimates. Its chief executive, Kenneth C. Frazier, said the company would no longer give longer-term forecasts.
Merck stock fell 1 cent to close at $32.89.
Shares in GlaxoSmithKline closed unchanged at $38.01 as investors cheered the resumption of a share buyback program. Pfizer stock also got a big boost earlier this week from adding billions of dollars to share buybacks.
Research pharmaceutical companies are facing a cascade of risks including price pressures in Europe and the United States, disappointments in some core research areas, and the loss of sales to generic competitors like Teva.
Elite Pharmaceuticals Announces FDA Approval for Generic Phentermine HCL Tablets
Elite Pharmaceuticals, Inc. (“Elite” or the “Company”) (OTCBB:ELTP) announced today the approval of an Abbreviated New Drug Application (ANDA) for phentermine HCl 37.5 mg tablets by the U.S. Food and Drug Administration (FDA). The phentermine HCl tablets are the generic equivalent of the Adipex-P® 37.5 mg tablets. The product and its equivalents had annual sales of approximately $40 million in 2010 and there are currently six other approved generic manufacturers plus the innovator. On September 16, 2010, Elite had previously announced the acquisition of the ANDA for this generic product from Epic Pharma LLC (“Epic”). The ANDA approval was granted under Epic Pharma’s name and transfer of the ANDA into Elite’s name will begin immediately.
Also previously disclosed on September 16, 2010, this product was part of a license agreement and a manufacturing and supply agreement (together the “Agreements”) with Precision Dose, Inc. (Precision Dose) which has a wholly owned subsidiary, TAGI Pharma, Inc. (“TAGI Pharma”) which will distribute the product. Pursuant to the previously disclosed Agreements, TAGI Pharma will market and sell this product and Elite will manufacture the product. Elite will receive a milestone payment upon shipment of the first product to Precision Dose and Elite will receive a percentage of the gross profit, as defined in the License Agreement, and earned by TAGI Pharma as a result of sales of the products. The license fee is payable monthly for the term of the License Agreement.
“Elite currently manufactures Lodrane 24® and Lodrane 24D® which are marketed by our partner, ECR Pharmaceuticals, for allergy treatment, and in addition to this phentermine product, we expect to launch two additional products this year that will be marketed by TAGI. Collectively, these products will allow the company to fully realize the implementation of the business plan that was put in place to turn the company into a profitable operational company,” commented Jerry Treppel, Chairman and CEO.
About TAGI Pharma, Inc.
TAGI Pharma was launched by Precision Dose in 2010 as a specialty pharmaceutical company focused on the Retail Market Segment. A key component of TAGI Pharma’s strategy is the leveraging of its sales and distribution core competencies with the formation of strategic partnerships with product development and manufacturing companies such as Elite. The phentermine HCL 37.5 mg product represents the first of these initiatives, and we expect an additional five product launches in the next six months. As the company sources products through development, acquisition and licensing opportunities, key areas of focus will be in the tablet, capsule and injectable dosage formats, with an emphasis on controlled substances, where there are additional barriers to entry. TAGI Pharma is located in South Beloit, Illinois, and additional information can be obtained from its website www.tagipharma.com.
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops and manufactures oral, controlled-release products using proprietary technology. Elite’s strategy includes the development of life cycle management products to lengthen the franchise life of drug products facing patent expiration, the development of controlled-release formulations of existing products to improve their clinical profile, and the development of generic versions of controlled-release brand drug products with high barriers to entry. Elite developed and manufactures for its partner, ECR Pharmaceuticals, Lodrane 24® and Lodrane 24D®, a non-sedating antihistamine for the treatment of allergy symptoms. The company recently purchased, and expects to soon launch three approved generic products. In addition, Elite has a pipeline of additional generic and branded drug candidates under active development. Two of the branded products under active development are ELI-216, an abuse resistant oxycodone product, and ELI-154, a once-a-day oxycodone product. Elite conducts research, development and manufacturing in its facility in Northvale, New Jersey.