Regulatory

FDA could lose 251 employees under the administration's proposed 2006 budget. The agency will try to do more with less through risk-management practices, but important tasks will fall by the wayside.

If the legislation passes, companies will be rewarded with a six-month extension of market exclusivity if they conduct pediatric trials. And under the proposal, companies that fail to comply can be penalized.

Class actions threaten industries that deal with the public. If European lawmakers remove the restriction on class-action suits, consumers will be free to file cases. Pharma companies should take heed.

My doctor and I have two different visions of an avian influenza pandemic. She's picturing regular flu season, but worse. I'm imagining 1918. Does the conflict sound familiar?

Integra v. Merck KGaA supports research by large pharmaceutical companies, but it also opens the door to greater use of compounded materials by all parties. Congress may have to clarify its scope.

SPCs extend a drug's basic patent protection for up to five years, to take into account the time that may have lapsed between the filing of a patent application and the granting of market authorization.

Manufacturers will have to incorporate Part D–specific messaging into all of their current marketing materials. In addition, they should consider publication plans and CME that specifically address the needs of seniors.

If congressmen gathered to work through the nuances of banning ED drugs from reimbursement under Medicare, they'd still back the ban. But the decision would be grounded in lack of faith in prescribing behavior, not disregard for a debilitating condition.

The cost of healthcare has become so great that it's important to review the evidence to determine whether the drug is a good value for the money. Yet, pharmacoeconomics is rarely included in the decision process.

If congressmen gathered to work through the nuances of banning ED drugs from reimbursement under Medicare, they'd still back the ban. But the decision would be grounded in lack of faith in prescribing behavior, not disregard for a debilitating condition.

Procter & Gamble Pharmaceuticals discovered that a network resulting from even a modest integration offered benefits that exceeded the sum of its parts.

For pharma companies large and small, one of the most pressing challenges of the next few years will be to understand compliance at a much deeper level, to obtain the tools to make it possible.

Pilot projects involving RFID technology are appearing at some major pharma companies. But uptake of RFID-based solutions remains limited due to concerns about accuracy, reliability, and ROI.

Traders say parallel distribution of drugs generates savings for patients. Industry says it creates more profits for traders, leaving pharma with less R&D funding.

State clinical trials requirements are in place to protect people from being exploited, or unsafely exposed to compounds. Forty years later, it's easy to say, "How did this happen?"

All too often, abuse liability and dependence potential are afterthoughts in the drug development process.

A prolonged QT interval creates an electro-physiological environment that is favorable for the development of cardiac arrhythmias.

CMS envisions studies to show which drugs keep patients out of hospitals or how certain treatments can reduce side effects. Such analysis would support decisions on best practices in using medications.

When Jim Dougherty joined Mcgraw-Hill almost 30 years ago, medical journal publishing was just plain different than it is today. The days of the "three-martini lunch" were slowly coming to an end. Yet many companies still determined their ad schedules based on relationships. There was also less competition: without DTC or the Internet, journals garnered larger percentages of pharma's marketing mix. Today, Dougherty is group vice president of McGraw-Hill Healthcare Information and president of the Association of Medical Publications (AMP), an organization of publishing firms in the medical field. Like many of his peers, Dougherty has witnessed-and continues to witness-the transformation of the field. The future is bright, he says, but most certainly uncertain.

Pharma execs and industry analysts say pharma's reputation has improved during the past year. The general public sees things differently. Research says a few select companies are to blame.

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.

A recently released report claims pharma hides bad clinical trial results and over-promotes drugs. Tougher regs are being called for.

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.