Regulatory

Just a decade ago, FDA was accused of dragging its feet on new drug applications. Now, supposedly, the agency is moving so fast that it's letting unsafe, insufficiently tested products into the marketplace.

OIG now requires corporate marketing departments and field sales reps to not only document how they promote products, but to also-for the first time-demonstrate the "intent" of marketing activities.

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.

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.

Reformers want to give FDA more clout, but agency officials say internal changes will help fix drug safety problems.

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.

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.

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.

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?

For companies that are prepared, Part D represents a great opportunity. For others, failing to react quickly enough could be a costly mistake.

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.