SOURCE: BioCentury This Week TV

BioCentury This Week TV

October 01, 2010 07:30 ET

FDA Top Official Explains Agency Decision Not to Pull Avandia, Explodes Drug Safety Myths

Exclusive Interview on "BioCentury This Week" TV Airing October 3

REDWOOD CITY, CA and WASHINGTON, DC--(Marketwire - October 1, 2010) -  In an exclusive interview to be aired on the October 3 "BioCentury This Week" TV show, FDA's Joshua Sharfstein, the agency's Principal Deputy Director, explodes some of the myths about drug safety and explains why the agency has made the controversial diabetes drug Avandia available to patients who need it.

This interview airs Sunday, October 3, at 8:30 a.m. EDT on the Gannett Broadcasting flagship station WUSA Channel 9, the CBS affiliate in Washington, D.C., and in Boston on Fox affiliate Channel 25. At 9:00 a.m. EDT on October 3, the program will be available via webcast at www.biocenturytv.com.

The entire program is devoted to the interview with Dr. Sharfstein, FDA's No. 2 official, who candidly describes the challenge of balancing risks and benefits of all drugs, cautioning that "an absolute assurance of perfect safety for drugs is not around the corner."

FDA's recent decision to leave GlaxoSmithKline plc's Avandia on the market comes with extraordinary restrictions on its use, now requiring physicians to sign a statement attesting to compliance with the approved indication before providing a prescription. Patients also must provide written acknowledgement that they understand the potential risks. Dr. Sharfstein explains that while marketing of the drug has been suspended in Europe, FDA made its decision not to pull Avandia based on the U.S. agency's power to impose a risk evaluation and mitigation strategy (REMS) defining access and use restrictions.

But these requirements may not be the final word. FDA has directed GSK to commission an independent re-adjudication of data from the RECORD Avandia cardiovascular outcomes study, and has suggested the results could lead to new regulatory decisions. On BioCentury This Week, Dr. Sharfstein says FDA has characterized the evidence on cardiovascular risk "as concerning but not definitive," and has built a solution to address its concerns while gathering more information.

The Avandia case has consumed enormous resources at FDA, which some members of Congress have accused of failing to protect patients from harm. Discussing the "difficult history of Avandia" on BioCentury This Week, Dr. Sharfstein comments on why the "shouting" about drug safety does not lead to good decisions, and what the debate has meant for the agency's hurdles for new diabetes drugs.

About "BioCentury This Week" TV
BioCentury This Week
, the first public affairs program of its kind to be broadcast on a major U.S. television station is a partnership of BioCentury Publications, Inc. and W*USA, the Gannett Broadcasting flagship station in Washington, D.C. The program joins the W*USA "Sunday Power Block" lineup, which includes CBS Sunday Morning; Face the Nation; This Week in Defense News; Platt's Energy Week and The McLaughlin Group. The 30-minute program began airing on September 19 in the Washington market on WUSA Channel 9 and in the Boston, Mass., market on Fox affiliate WFXT Channel 25.

Each Sunday's broadcast is streamed from the "BioCentury This Week" website, www.biocenturytv.com, so that viewers around the world can connect to the program's timely discussions on important developments in healthcare, nutrition and energy that are affecting the way people live and work. Charter Sponsors of "BioCentury This Week" include Biogen Idec Inc., a global leader in the discovery, development, manufacturing and marketing of innovative therapies; the Biotechnology Industry Organization (BIO), representing more than 1,200 biotechnology companies, academic institutions and related organizations in the U.S. and 30 countries; and Rodman & Renshaw, a full-service investment bank.

About BioCentury
Now in its 18th year, BioCentury® is internationally recognized as the leading provider of news, analysis and opinion about biotechnology, including emerging technology, product development, industry strategy and finance, regulation and public policy. The company publishes the weekly journal BioCentury: The Bernstein Report on BioBusiness and BioCentury Extra, a daily online newspaper. BioCentury also publishes SciBX: Science-Business eXchange, a translational science journal in partnership with Nature Publishing Group, and markets BCIQ: BioCentury Online Intelligence, a data solutions product for biopharma industry and investment professionals. The company is widely acknowledged in the life science corporate and investment communities for pioneering the creation of three annual conferences in the U.S. and Europe that provide turf-neutral venues for biotech investors, pharmaceutical licensing professionals and corporate executives to conduct business. BioCentury Publications, Inc. is headquartered in Redwood City, California, with offices in Washington, D.C.; Chicago; Chadds Ford, Penn.; and the U.K.

About W*USA
W*USA is owned by the Gannett Company Inc. (NYSE: GCI). Gannett is an international news and information company operating on multiple platforms including the Internet, mobile, newspapers, magazines and TV stations. Gannett is an Internet leader with hundreds of newspaper and TV Web sites; CareerBuilder.com, the nation's top employment site; USATODAY.com; and more than 80 local MomsLikeMe.com sites. Gannett publishes 84 daily U.S. newspapers, including USA TODAY, the nation's largest-selling daily newspaper, and more than 700 magazines and other non-dailies including USA WEEKEND. Gannett also operates 23 television stations in 19 U.S. markets. Gannett subsidiary Newsquest is the United Kingdom's second largest regional newspaper company with 17 daily paid-for titles, more than 200 weekly newspapers, magazines and trade publications, and a network of Web sites. Gannett TV stations are: WATL-TV, Atlanta, WXIA-TV, Atlanta, WLBZ-TV, Bangor, Maine, WGRZ-TV, Buffalo, N.Y., WKYC-TV, Cleveland, Ohio, WLTX-TV, Columbia, S.C., KTVD-TV, Denver, Colo., KUSA-TV, Denver, Colo., KNAZ-TV, Flagstaff, Ariz., WZZM-TV, Grand Rapids-Kalamazoo-Battle Creek, Mich., WFMY-TV, Greensboro, N.C., WTLV-TV, Jacksonville, Fla., WJXX-TV, Jacksonville, Fla., WBIR-TV, Knoxville, Tenn., KTHV-TV, Little Rock, Ark., WMAZ-TV, Macon, Ga., KARE-TV, Minneapolis-St. Paul, KPNX-TV, Phoenix, Ariz., WCSH-TV, Portland, Maine, KXTV-TV, Sacramento, Calif., KSDK-TV, St. Louis, Mo., WTSP-TV, Tampa-St. Petersburg, Fla., WUSA-TV, Washington, D.C.

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