Congress will not legislate generic biotech medications
WASHINGTON Generic biotech medications will not be included in the upcoming drug safety legislation in the U.S. Congress later this month, Reuters reported. According to aides to lawmakers from both chambers, the opposition is coming from House members, who want to hold more hearings to give the issue a closer look.
The provision on generics is “off the table,” Michael Mahaffey, a spokesman for the Senate health committee Republicans, said in an interview, Bloomberg reported. “There’s a widespread general agreement that’s something they’d take up another time.”
Sales of biotech drugs were more than $40 billion last year, according to IMS Health. Generic competition may cut the price of the medicines by a third, analysts say.
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.