Regulatory

In an opinion piece in the September 8 New England Journal of Medicine, Harvard medical professor and long-time industry critic Jerry Avorn takes a whack at FDA, accusing the agency of practicing a level of science that wouldn’t pass muster anywhere else in research-science that’s only "good enough for government work.";

Many still regard FDA's approach as costly and unnecessary. But the prospect of qualifying for purchase by PEPFAR is attracting applicants. The policy has helped bring news AIDS treatments to market.

Think of the role compliance plays in your job. Now imagine that level of concern increased by 25 percent, 50, or even more. That's what pharma has to look forward to in the next few years, as the effects of old regulatory initiatives, such as 21 CFR Part 11 and Sarbanes Oxley, start fully kicking in-and as we experience the as-yet-unknown regulatory fallout of the new concern with drug safety. It's no surprise that a great portion of this volume of Pharm Exec's Successful Product Manager's Handbook series is given over to compliance.

Product managers would be less disrupted if compliance activities at pharma companies were more anticipatory than reactionary.

UK courts are affirming the belief that medical research and drug development have made a huge contribution to people's quality of life, and that a small but vital part of that work involves the use of animals.

The pharmaceutical industry devotes more of its promotional budget to samples than anything else, unless you count the army of sales representatives that delivers them. This year, the average wholesale price of samples passed out to doctors will approach $15 billion-roughly twice the value of samples five years ago. And although few in the industry have come to grips with it, the federal regulations governing this enormous investment have undergone drastic changes.

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.