Pharma News In Brief

New White House Advisory Panel On Competitiveness

Newly-established Council on Jobs and Competitiveness will focus on promoting innovation, increasing the U.S. manufacturing base and expanding exports, council Chairman Jeffrey Immelt said in an editorial published in the Washington Post Jan. 21. Immelt, who is chairman and CEO of General Electric, said government should “incentivize” corporate investment in innovation, a theme being emphasized by the Pharmaceutical Research and Manufacturers of America (Also see "PhRMA's Policy Pitch: Protect Industry Innovation Or We Go The Way Of Auto Makers" - Pink Sheet, 20 Jan, 2011.). Formation of the council was announced by the White House Jan. 21. It will replace and build on the efforts of the President’s Economic Recovery Advisory Board, which has operated over the past two years under the leadership of Paul Volcker. Immelt also served on that board.

PhRMA Former Public Affairs Exec Returns To E&C Committee

Former Pharmaceutical Research and Manufacturers of America Senior VP Communications and Public Affairs Ken Johnson has returned to Capitol Hill to work for Rep. Mary Bono Mack, R-Calif., chair of the Energy and Commerce Committee’s Subcommittee on Commerce, Manufacturing and Trade. Johnson will be senior advisor for policy and communications for Bono Mack. He was deputy chief of staff and chief spokesman for the Energy and Commerce Committee from 2001-2004 under then-Chairman Billy Tauzin and Johnson joined PhRMA when Tauzin was named CEO of the association in 2005. He left PhRMA after Tauzin resigned from the association in June (Also see "PhRMA Chief Billy Tauzin Stepping Down" - Pink Sheet, 15 Feb, 2010.). Johnson’s tenure with Tauzin involved some major pharma industry developments – passage and implementation of the Medicare Part D program and the industry’s health reform deal with the White House. In his new job, Johnson’s focus will be on jobs creation, according to a release from Bono Mack’s office.

Vivus Meets With FDA On Qnexa "Complete Response"

FDA's latest concerns about Vivus, Inc.'s obesity drug Qnexa (phentermine/topiramate) apparently derive from published reports of oral clefts and cleft lips from pregnancy registries, Vivus reported after a Jan. 19 meeting with the agency. Two oral clefts were recorded in the U.K. Epilepsy and Pregnancy Register and four, including two isolated cleft lips, appeared in the North American AED Pregnancy Registry, Vivus said, adding that among the 15 women who gave birth during Qnexa clinical trials, no fetal malformations were reported. Topiramate's teratogenicity has been an known issue, coming up at its July 2010 advisory committee review and in the Oct. 28, 2010 "complete response" letter. The panel voted against approval, citing concerns over lack of risk information and off-label use (Also see "REMS For Obesity Drugs May Need More Specifics After Qnexa Advisory Panel" - Pink Sheet, 19 Jul, 2010.). In the action letter, FDA asked for an assessment of teratogenic potential and evidence that elevated heart rates seen with Qnexa do not increase risk for adverse cardiovascular events. FDA has asked the firm to assess the feasibility of analyzing existing health care databases to determine the historical incidence of oral cleft in offspring of women treated with topiramate 100 mg for migraine prophylaxis. Topiramate is marketed as Topamax by Ortho-McNeil Janssen Pharmaceuticals, Inc. For migraine prevention, it is dosed at 100 mg/day. Labeling urges physicians to encourage patients who become pregnant while taking the drug to enroll in the NAAED registry. (For epilepsy in adults, Topamax is administered at doses up to 400 mg/day.)