Regulatory

Arguments over DTC have become more sophisticated, and there is much more middle ground.

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 most salient feature of the Medicare prescription drug benefit is its uncertainties. That was perhaps the key insight at a roundtable conducted by Pharmaceutical Executive in conjunction with the executive summit "Medicare Part D: Can There Be Alignment Between Government Goals and Industry Opportunity?" cosponsored by this magazine and Model N, a revenue management-solution provider. With a panel that included representatives from pharma, the legal community, prescription benefit managers, and data and service providers, the roundtable looked at the goals of Part D, the threats and opportunities it presents to stakeholders, the skills companies need to develop, and the way the playing field is likely to change over the next few years. What follows is an edited version of the conversation.

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.

Medicare's Competitive Acquisition Program takes a shot at reforming Part B drug distribution. But the new rules evoke a vast and complicated Rube Goldberg machine, where nobody gains much-except CMS.

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.

Increased availability of clinical-trials information allows patients to identify trials in which they may participate, assess safety issues, and easily register.

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 client-agency relationship is a product of its environment. Chock-full of regulatory requirements, scandals, and heightened FDA scrutiny, the current environment leaves much to be desired. But this is hardly news for the pharma industry.

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.

Implementation of policies that respond to industry compliance standards poses a considerable burden for companies in terms of time and expense. Unless industry changes its response to state laws, the condition will worsen.

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.