Industry, health groups’ alarm grows as tamper-proof deadline approaches
ALEXANDRIA, Va. Intensifying their alarm warnings as the deadline for shifting to tamper-resistant prescription pads rapidly approaches, a coalition of more than 100 national and state pharmacy and health groups has issued a new appeal to Congress to delay the adoption of the rule by one year.
The latest appeal came in an urgently worded letter sent Monday to four key members of the House and Senate, including Sen. Max Baucus, the Montana Democrat who chairs the Senate Finance Committee; and Rep. John Dingell, D-Mich., chairman of the House Energy and Commerce Committee. The letter is co-signed by 34 national and 83 state and local associations including the National Association of Chain Drug Stores, the National Community Pharmacists Association, the American Medical Association and the American Dental Association.
Authored by the National Association of State Medicaid Directors and the American Public Human Services Association, the letter seeks a one-year delay in enacting the provision of the Iraq War Supplemental Appropriations bill that requires all Medicaid prescriptions to be written on tamper-proof pads beginning Oct. 1, 2007.
“States are reporting that uniform compliance with the new requirement by the Oct. 1 deadline is not possible due in large part to the extremely tight timeframe of the legislation,” the coalition noted in its letter. “The guidance [that] states needed to administer this new initiative was just issued on Aug. 17, which gives states roughly six weeks to notify providers, pharmacies and recipients.”
Among the concerns voiced by physicians, pharmacy retailers and other providers, the letter states, “is our ability to notify human service agency clients of the change in the requirement and allow adequate time for them to return to physicians’ offices prior to the deadline.”
NACDS president and CEO Steven Anderson pledged his organization would “continue to fight for a more adequate time period” to implement the rule.
“With the current implementation date of Oct. 1, an unacceptable risk is posed that Medicaid patients may not receive their medication,” Anderson said.
GSK flu vaccine facility in Quebec is nearly completed
QUEBEC CITY, Canada GlaxoSmithKline said that it is near completion of its Quebec City manufacturing facility, used to develop the company’s influenza vaccine.
After a two-year—and $199 million—investment to upgrade the manufacturing site, the location will increase the capacity of vaccine doses to 75 million per year, the company said. The expansion has also given way to providing this facility, and existing ones, new equipment and other innovative technologies to assure efficient production.
The company has also doubled the size of its vaccine workforce in Quebec City since January 2006.
“[This] announcement reinforces the key role that both Quebec and Canada play in GSK’s global vaccine business,” said Michel Baijot, vice president of Worldwide Strategic Alliances and Business Development, GlaxoSmithKline Biologicals, the company’s vaccine division. “Through this investment, Quebec and Canada will have an impact on global health by supporting countries in their influenza pandemic planning.”
According to GSK, the company supplies about 75% of the Canadian government’s seasonal flu vaccine purchases and will also provide Canada with a pandemic vaccine in the event of an influenza pandemic.
FDARA attempt to limit citizens petitions not likely to have much effect, expert claims
WASHINGTON According to Richard Silver, senior vice president of Equity Research for Lehman Brothers, the Food and Drug Administration’s Revitalization Act, which included language intended to limit the use of citizen petitions to block approvals of generic drugs, will not stop their use by brand companies, the FDA reported.
“Citizen’s petitions … we do not think they’re going to go away. The backlog continues to grow,” Silver said last week during the Generic Pharmaceutical Association’s Annual Policy Conference in Washington, D.C. “We don’t think the citizen’s reforms will change the behavior of brand companies significantly.”
Two versions of the legislation are currently pending before a conference committee.