OIG accuses FDA of severe lack of oversight
WASHINGTON According to a report by the Department of Health and Human Services Office of the Inspector General, the Food and Drug Administration does not know how many clinical trials are going on at any given time.
The report also said that the FDA is unaware of how many sites are conducting these trials and how many institutional review boards are overseeing them. The FDA’s over reliance on voluntary compliance by the recipients of warning letters and other weaknesses in information systems and management processes harm its oversight of clinical trials.
“Warning letters and untitled letters rely on voluntary compliance, so [the] FDA must re-inspect individuals who receive these letters to ensure that they do not repeat violations in future clinical research,” the OIG report says.
President Bush signs bill for delay of tamper-resistant prescriptions
ALEXANDRIA, Va. The National Association of Chain Drug Stores thanked President Bush on Monday for his quick action in signing a bill which would extend the implementation date requiring all Medicaid prescriptions to be written on tamper-resistant prescription paper, originally set at Oct. 1.
In a communication to the White House last week, Steve Anderson, NACDS president and chief executive officer, stated, “Without the delay, we anticipate that Medicaid patients will not receive the medications they need in a timely fashion. Disruptions in medication therapy result in human costs and more costly downstream treatments that negatively affect the entire health care system.”
The six-month delay was included as part of H.R. 3668, which also extends certain health care programs that would have expired on the same date.
A provision tucked into an Iraq war spending bill (Public Law 110-28), finalized on May 25, required doctors and other prescribers to write prescriptions on tamper-resistant prescription pads for Medicaid patients beginning October 1, 2007.
NACDS led the charge in seeking a delay of the tamper-resistant requirement, arguing that four months was not enough time for regulators, doctors, pharmacists and prescription pad manufacturers across the country to comply with such a widespread change. With 300 million Medicaid prescriptions filled annually, this requirement would have led to serious disruptions in patient care.
“We cannot express our thanks to President Bush enough for helping low-income Americans continue to receive their prescription medications,” said Anderson. “If the bill was not enacted by today—Oct. 1—the nation’s community pharmacists would have had to choose between serving their patients and being reimbursed for the Medicaid prescriptions they fill—a decision no pharmacist should have to face.”
This issue was an urgent priority for NACDS. However, the organization points out that community pharmacy still faces a much larger threat—a new benchmark, Average Manufacturer Price, that will cut Medicaid pharmacy reimbursements by over $8 billion.
“This six-month delay is crucial to protecting patient access to medications, and it’s an important victory for community pharmacy,” said Anderson. “But we can’t rest. We must continue fighting to ensure that reimbursement cuts do not threaten the ability of pharmacists to serve low-income patients.”
FDA gives tentative approval to Teva’s generic Valtrex
JERUSALEM Teva has received tentative approval from the Food and Drug Administration to market a generic version of GlaxoSmithKline’s herpes drug Valtrex, according to the Associated Press.
Final approval on the generic will be expected in December 2009 after the patent expires on the brand. Mylan has also received tentative approval for a generic version of Valtrex as well.
Valtrex had sales of about $1.3 billion last year.