FDA bill currently in consideration to regulate prescription drug advertising
WASHINGTON A new user fee program for Direct-To-Consumer broadcast ads will soon be put into law as part of a Food and Drug Administration bill working its way through Congress.
As a result, sponsors will soon have to tell the FDA how many of these ads it expects to submit for pre-view during the fiscal year 2008. Otherwise, you can be charged 50 percent for late penalty fees or lose your payment if you underestimate the number of ads you’ll run.
The FDA will be given power to determine what is acceptable and what is not, so it will be the job of the sponsors to conform to the FDA’s requirements to avoid those extra fees. The ads could be priced anywhere from $62,500 to $83,000, depending on how much money the FDA will need to keep the program going.
BMS to acquire biologics developer for $430 million
PRINCETON, N.J. Bristol-Myers Squibb has signed an agreement with Adnexus Therapeutics, under which BMS will acquire Adnexus, a developer of a new therapeutic class of biologics called Adnectins.
Under the agreement, Adnexus will become a subsidiary of BMS and advance BMS’ biologics, with its Phase I oncology biologic, Angiocept. BMS will acquire all of Adnexus’ issued and outstanding shares of stock for $430 million. There also is another $75 million that could be paid to Adnexus, in three separate payments, depending on development and regulatory milestones.
“Bringing Adnexus into the Bristol-Myers Squibb family builds upon a successful and productive collaboration between the two companies in oncology and is an important step in accelerating the strategic transformation of our pharmaceutical business to a biopharma business model,” said Jim Cornelius, chief executive officer of BMS.
Building new bridges to e-prescribing, SureScripts turns to vendors for advice
ALEXANDRIA, Va. SureScripts, the pharmacy-sanctioned electronic prescription platform provider, revealed today the formation of a 10-member advisory group charged with spurring the nationwide adoption of e-prescribing.
Composed of technology and electronic communications experts, the Prescriber Vendor Advisory Council will work with SureScripts on programs to boost the use of e-prescribing by U.S. physicians, the company said in a statement. “As part of its mission, the council will provide insight on key variables that are known to impact a physician’s decision to begin e-prescribing and their level of satisfaction once they start,” explained SureScripts spokesman Rob Cronin.
Members of the council are experts in the design and application of information technology used by physicians, according to the company. The group will convene this week, and will focus on such areas as technology design and programs to support the adoption by doctors of e-prescribing software. Together with SureScripts, the new advisory council will explore such topics as “how changes in electronic prescribing technology and making fuller use of pharmacy interoperability can improve the … workflow by professionals in the physician’s office and behind the pharmacy counter,” Cronin noted.
“Even the most compelling of new technologies will invariably face obstacles that slow adoption, and this has never been more true than in health care,” said Rick Ratliff, the company’s chief operating officer. “SureScripts will work with its Prescriber Vendor Advisory Council to identify and address these obstacles.”