Valeant announces Spear to halt generic Efudex persuant to lawsuit against FDA
ALISO VIEJO, Calif. Spear Pharmaceuticals has agreed to not market, sell or ship the drug fluorouracil cream 5 percent, a generic of Valeant Pharmaceuticals Efudex in relation to legal action Valeant is taking against the Food and Drug Administration. The agreement to hold off the generic will remain in place until at least May 14.
On April 11, the FDA approved an application for a fluorouracil cream 5 percent sponsored by Spear Pharmaceuticals. On the same day, the FDA responded to Valeant’s Dec. 21, 2004, citizen petition regarding potential generic versions of Valeant’s pioneer drug product, Efudex.
The drug is approved by the FDA for the treatment of multiple actinic or solar keratoses, and for the treatment of superficial basal cell carcinomas when conventional methods of treatment are impractical.
In the citizen petition, Valeant requested that the FDA decline to approve generic versions of Efudex where the generic company has failed to provide test data comparing the generic product to Efudex in patients diagnosed with superficial basal cell carcinoma, a form of skin cancer.
On April 25, Valeant filed a federal lawsuit against the secretary of Health and Human Services, Michael Leavitt, and the commissioner of the FDA, Andrew von Eschenbach, challenging the FDA’s denial of Valeant’s citizen petition and the approval of a generic to Efudex. Valeant requested a temporary restraining order to suspend the FDA’s approval of Spear’s application. Following an initial round of briefing, the FDA requested and obtained from the court a two week wait of the lawsuit. In addition, Spear Pharmaceuticals informed the court it will suspend all further sales and shipment of its product for the duration of the court ordered stay.
Wal-Mart’s $4 generic program expanded again
BENTONVILLE, Ark. Wal-Mart’s $4 generic drug program was expanded on Monday to include new elements such as a 90-day, $10 option, several new women’s medicines and 1,000 nonprescription medicines priced at $4 or less.
This is the third time the program has been expanded since it was introduced in the fall of 2006. Since then, Wal-Mart contends, it has saved customers more than $1.1 billion and up to 95 percent of the prescriptions written in the majority of therapeutic categories now are included in the $4 prescription program. In addition, customers now can purchase a 90-day supply of 350 medicines for $10, a change Wal-Mart said gives customers an additional choice and saves them time and money.
Other changes include the addition of medicines such as a generic version of the osteoporosis drug Fosamax for $9 for a 30-day supply or $24 for a 90-day supply. In addition, medications to treat breast cancer (tamoxifen), menopause and hormone deficiency were added to the list of $9 medicines, a pricing tier that was added to the program in September 2007.
The other notable change to the program involved the inclusion of branded and private-label nonprescription drugs. More than 1,000 products, roughly one-third of the OTC drugs available at Wal-Mart and Neighborhood Market stores are available for $4.
“We’re succeeding in our efforts to deliver simple, affordable, quality pharmacy solutions for families struggling with the rising costs of health care,” said John Agwunobi, president of Wal-Mart’s health and wellness division.
Wal-Mart has promoted the $4 program extensively since its introduction via television commercials, print ads and signage throughout its stores to encourage customers to visit the pharmacy. In addition, the $4 program is frequently held up by Wal-Mart senior executives as an example of the retailer’s marketing slogan adopted last summer to help customers save money so they can live better.
IDSA agrees to re-examine chronic Lyme disease guidelines
HARTFORD, Conn. The Infectious Diseases Society of America has agreed to review its guidelines, which say there’s no evidence long-term antibiotics can cure “chronic” Lyme disease—or even that such a condition exists, according to the Washington Post.
The agreement, announced Thursday, calls for the doctors group to form a new panel of experts to review standards for treating Lyme disease. The IDSA says it agreed to the deal in part because the panel must be made up of doctors and scientists.
Lyme disease can be hard to diagnose with its vague, flu-like symptoms; the most obvious sign is its trademark round red rash. Usually, it’s easily cured with a few weeks of antibiotics. Those not promptly treated can develop arthritis, meningitis and other serious illnesses.
The IDSA says it’s never been proven whether these patients still have Lyme disease or something else. The group continues to defend its standards, which say short-term antibiotics are effective for nearly all patients. Long-term antibiotics are unproven and potentially dangerous, because overuse of the drugs can lead to drug-resistant infections, the society says.
“We are confident that our guidelines for the diagnosis and treatment of Lyme disease represent the best advice that medicine currently has to offer … and we look forward to the opportunity to put to rest any questions about them,” said Donald Poretz, the society’s president.
The society will consider a variety of scientific evidence and determine whether the 2006 guidelines are justified or need revision.
The guidelines are important because they discourage adequate treatment, advocates of chronic Lyme sufferers say. Perhaps just as significant is that insurance companies refuse to pay for long-term antibiotics to treat chronic Lyme disease because they follow the panel’s guidelines.
The doctors group makes clear that current guidance for treating Lyme disease remains in place.