Bill to open biogeneric approval path wins strong endorsement from NACDS
ALEXANDRIA, Va. A new initiative in Congress to promote the regulatory approval and marketing of generic versions of biotech drugs won a strong endorsement Monday from the National Association of Chain Drug Stores.
The new legislative push comes from H.R. 1427, the Promoting Innovation and Access to Life-Saving Medicine Act. The bill, sponsored by House Energy and Commerce Committee Chairman Henry Waxman (D-CA), Reps. Nathan Deal (R-GA), Frank Pallone (D-NJ) and Jo Ann Emerson (R-MO), would give the Food and Drug Administration authority to approve interchangeable biogenerics – also known as follow-on biologics – when scientifically justified.
The bill’s cosponsors are framing the issue as one of controlling prescription drug costs.
In a letter to the bill’s authors, NACDS president and CEO Steven Anderson voiced support for the measure, and agreed that “increasing generic drug utilization is one of the most effective ways to control prescription drug costs.”
“Unquestionably, passage of H.R. 1427 would result in billions of dollars in savings to our nation’s healthcare system, and these savings are badly needed to fund important reforms in our healthcare system,” Anderson told lawmakers. “We believe that one logical way to apply these savings is in correcting the flawed pharmacy reimbursement policy established under the Deficit Reduction Act (DRA) of 2005.”
NACDS also supports the compromise approach taken by Waxman and his colleagues in the House of Representatives to clear an approval pathway for biogenerics. H.R. 1427, Anderson writes, “strikes the correct balance between rewarding innovation and encouraging competition. By providing a generous period of marketing exclusivity – up to eight years – it recognizes the importance of compensating brand manufacturers and encouraging research and development. Equally important, H.R. 1427 also provides the FDA with the authority to approve interchangeable biogenerics when scientifically justified.
“Determining interchangeability paves the way for allowing pharmacists to substitute generic biopharmaceuticals for their brand counterparts, which is vital to reducing prescription drug costs and expanding access for patients,” Anderson added.
CV Therapeutics’ board of directors rejects Astellas’ tender offer
PALO ALTO, Calif. The board of directors of CV Therapeutics announced Friday it has rejected Astellas’ tender offer of $16 per share.
CV Therapeutics’ determined that the offer “undervalues the company and is not in the best interests of its stockholders”, according to a release.
The announcement comes once day after Gilead Sciences announced it would acquire CV Therapeutics, making it a wholly owned subsidiary of Gilead. The transaction is valued at approximately $1.4 billion, with a tender offer of $20 per share.
Take Care Health Systems opens new clinic in Phoenix
CONSHOHOCKEN, Pa. Take Care Health Systems, which is owned by Walgreens, has opened a new clinic in the Phoenix market, the clinic operator announced on Friday.
With the new opening, the company now has 18 clinics in that market.
Take Care Health Systems operates a total of 339 clinics in 35 markets throughout 19 states.