Regulatory

One health insurance company in The Netherlands is offering doctors a financial incentive to prescribe generic statins and proton pump inhibitors. Doctors and patients complained, but a court upheld the practice.

FDA doesn't usually write a black box warning "without some pretty good data," said Robert Temple of FDA's Office of Medical Policy. Overuse of the black box can both dilute its impact and limit access to needed treatment.

Drugs are not directly addressed in Europe's new legislation for chemicals. But they'll be affected, because chemicals are used in drug manufacturing.

Pharmaceutical companies are worried that FDA's new labeling format will expose them to liability suits from individuals who suffer adverse events that are not highlighted, but "hidden" in the full prescribing information.

While CMS officials praise the CED policy as a way to extend Medicare coverage, patients and industry fear the agency won't reimburse for innovative treatments unless sponsors support post-approval studies.

Is the public ready for an exciting thriller about terrorism, drug counterfeiting, valiant FDA agents, and glamorous women who invite pharma CEOs to come up and look at their drug patents? Sure. Maybe someone should write one.

The omission of criminal charges for off-label promotion of Serostim is surprising, because the government's earlier plea with Pfizer sent a strong signal that it would criminally charge companies engaged in off-label marketing.

Often, post-approval marketing studies don't materialize because drug companies question their value. Independent review of the need for such studies would address pharma's concern that they may be warranted.

To Janet Woodcock, Critical Path hasn't been dying, it's been getting work done."People shouldn't underestimate the difficulties of creating new models. A lot of things worth doing can't happen quickly."

FDA wants flexibility to use user-fee revenues to extend drug safety oversight, to review direct-to-consumer advertising before it goes public, and to modernize the ever longer and more complex drug development process.

Serious offenders of the new Association of the British Pharmaceutical Industry's Code of Practice can be "named and shamed" with adverts in the trade press. Details of breaches by companies will be posted online.

Patient-Program Interface Nearly one-third (2.5 million) of the estimated eight million Americans currently enrolled in PAPs are over age 65 and will be eligible to participate in the government's Part D program.

The public is focused on drug safety, but the real issue isn't approval standards. It's the way drugs expand to unapproved new indications. Are you listening, Acomplia?

FDA may be receiving fewer new drug applications for truly innovative products, but it has been overwhelmed this year with 800 abbreviated NDAs for generic drugs and thousands of supplements.

Despite heightened scrutiny from industry advocates and the beginnings of self-imposed regulation, pharma companies' violations of DTC regulations have been getting worse, says Tom Abrams, director of FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC). Abrams has been on all sides of drug marketing, from receiving promotions as a pharmacist to creating promotions as a member of industry to regulating promotions as the head of DDMAC. As such, he's in good position to see the big picture.

The circumstances of Crawford's departure may complicate the process of securing a permanent FDA leader. Congress and HHS are investigating whether his confirmation process failed to uncover important facts.

Genentech and Biogen's MabThera has been awaiting NICE appraisal for three years. Merck KGaA's Erbitux has waited two-and-a-half years. A ruling on AstraZeneca's Arimidex isn't expected for more than a year.

Under one bill, states could license patented drugs to generics companies, paying patent holders a royalty.

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.