FDA announces PDUFA fees to go for increased safety
WASHINGTON The Food and Drug Administration says it will significantly expand its post-marketing safety activities, adopting new scientific approaches to drug safety to meet its commitments under the Prescription Drug User Fee Act.
The agency plans to spend its PDUFA IV fees to fund epidemiology best practices and data acquisition ($7 million in fiscal 2008, increasing to $9.5 million in fiscal 2012); new drug trade name review ($5.3 million in fiscal 2008, rising to $6.5 million in fiscal 2012); and risk management and communication ($4 million in fiscal 2008, rising to $5 million in fiscal 2012).
In a draft drug-safety five-year plan that the agency issued last week and updates annually, the FDA says it intends to use the fees to increase the number of employees dedicated to adopting new scientific approaches to drug safety, reducing the risk of medication errors and improving adverse event detection and prevention programs.
The FDA cites problems in adverse event reporting for marketed drugs due to “under-reporting, the often poor quality of reports and the lack of systematic feedback to healthcare providers and consumers.” To address this, the agency plans to hire a contractor “to study the various mechanisms for collecting adverse events and determine optimal strategies for collecting adverse event data throughout the product lifecycle,” according to the plan.
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.