Regulatory and Washington

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday launched the advisory committee membership nomination portal, an online, interactive system that allows interested individuals to submit nominations for membership to any of the agency’s 33 advisory committees.  

BINGHAMTON, N.Y. — New York Gov. Andrew Cuomo is set to include $10 million in his 2014-2015 executive budget proposal for Binghamton University to commence site acquisition and design work for a School of Pharmaceutical Sciences and Pharmacy.

WASHINGTON — According to an economic impact analysis released Tuesday by Martin Kennedy, a former professor of economics who spent seven years on the faculty of Middle Tennessee State University, adopting a prescription requirement for pseudoephedrine products in Tennessee would result in an influx of more than 497,000 additional physician office visits at a direct cost of $44.3 million annually.

DUBLIN — Actavis last week confirmed that the U.S. District Court for the District of New Jersey found United States Patent No. 7,704,984 (the '984 Patent) to be valid and infringed by Lupin Pharmaceuticals and Amneal Pharmaceuticals Abbreviated New Drug Applications (ANDAs) for generic versions of Actavis' Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets).  

Lo Loestrin Fe is a prescription birth control pill used for the prevention of pregnancy.

WASHINGTON — The Consumer Healthcare Products Association on Monday responded to Sen. Charles Schumer’s, D-N.Y., recent call for the Food and Drug Administration and the Consumer Product Safety Commission to require flow restrictors on all bottles of children's liquid medicines.

JERUSALEM — Teva Pharmaceutical on Tuesday announced that it has entered into a definitive agreement under which Teva will acquire NuPathe for $3.65 per share in cash, or approximately $144 million. In addition to the upfront cash payment, NuPathe shareholders will receive rights to receive additional cash payments of up to $3.15 per share if specified net sales of NuPathe's migraine treatment, Zecuity, are achieved over time.

MALVERN, Pa. — Endo Health Solutions on Tuesday announced that NuPathe has terminated its merger agreement. Endo received a $5 million termination fee from NuPathe.

WASHINGTON — The Food Marketing Institute, a plaintiff in the litigation against the Federal Reserve’s interpretation of debit reforms legislated by Congress under the Durbin Amendment, on Friday urged the Appeals Court to agree with U.S. District Court Judge Richard Leon’s July 31 decision. 

Judge Leon ruled that the U.S. Federal Reserve had “clearly disregarded” Congress’ intent “by inappropriately inflating all debit card transaction fees by billions of dollars.”