Regulatory

May 01, 2005
Pharmaceutical Executive
The future of US healthcare is being created today in Medicare's demonstration programs. But how you respond to them depends a lot on what kind of company you are.
Apr 01, 2005
Pharmaceutical Executive
Reformers want to give FDA more clout, but agency officials say internal changes will help fix drug safety problems.
Apr 01, 2005
Pharmaceutical Executive
Could it be that someone's finally going to wipe the grin off Smiling Bob's face? As we were putting this issue to bed, the Cincinnati newspapers reported that federal agents had raided the offices of Berkeley Premium Nutraceuticals, a company best known for its "natural male enhancement" pill, Enzyte, and for its repulsive television commercials starring Bob. The US Postal Service led the operation, which also included the FBI, IRS, and FDA. They froze bank accounts, sent employees home, and combed records, attempting to determine whether Berkeley, which has accumulated more than 5,000 complaints with the Cincinnati Better Business Bureau and the Ohio attorney general's office since 2001, had committed mail fraud.
Apr 01, 2005
Pharmaceutical Executive
Every quarter, pharmaceutical manufacturers confront a dizzying array of price reporting obligations. Participation in the Medicare, Medicaid, Veterans Administration (VA), and Public Health Service (PHS) programs requires manufacturers to collect, organize, distill and manipulate vast quantities of information, and to generate from that data reportable figures that can have an enormous impact on the company's bottom line. It is critical that these figures be correct, not only to help ensure the integrity of these public programs, but because submission of false data to a federal agency is a prosecutable criminal offense, and the civil penalties and exposure can be staggering.
Mar 01, 2005
Pharmaceutical Executive
Should policy makers expect 90 percent of seniors to enroll in PDPs, or will 75 percent be enough? Will the program have to keep costs down to $400 billion a year, or will spending be linked to savings elsewhere?
Mar 01, 2005
Pharmaceutical Executive
By Pharmaceutical Executive Editors
In the drug safety debate, we're hearing plenty of potential solutions. They're smart and advance desirable goals. There's just one thing wrong with them: They don't solve the problem.
Mar 01, 2005
Pharmaceutical Executive
By Pharmaceutical Executive Editors
If the Aspen model works, it could change the model for the developing world. Research-based companies could focus on R&D, and leave the manufacturing to generic companies.
Mar 01, 2005
Pharmaceutical Executive
Pharma companies in Europe believe that it already takes too long for new medicines to reach patients. Separate bodies for efficacy and safety will lead to further delays.
Feb 01, 2005
Pharmaceutical Executive
One response to today's safety concerns is particularly alarming: The research community has become skittish about conducting clinical studies involving pain medications and other high-risk treatments.
Feb 01, 2005
Pharmaceutical Executive
For companies that are prepared, Part D represents a great opportunity. For others, failing to react quickly enough could be a costly mistake.
native1_300x100
lorem ipsum