Washington Report

Dec 01, 2007
Pharmaceutical Executive
The ultimate goal is for the medical system to develop new evidence as a natural by-product of delivering appropriate care
Nov 01, 2007
Pharmaceutical Executive
FDAAA aims to restore public trust in drug safety regulation but may curb investment in R&D
Oct 01, 2007
Pharmaceutical Executive
There has been a lot of good news about the Medicare drug benefit in recent weeks. Surveys show a substantial increase in coverage, particularly among low-income seniors. Costs are less than expected; employers continue to offer retiree benefits; major insurers are sticking with the program; and product coverage remains fairly broad. Beneficiaries seem generally satisfied with the program, and the much-feared "doughnut hole" appears less lethal than anticipated (see "A Narrow Gap").
Sep 01, 2007
Pharmaceutical Executive
As expected, must-pass legislation to reauthorize the Prescription Drug User Fee Act (PDUFA IV) has provided a vehicle to renew numerous programs and to establish new policies to ensure the safe use of medications. The measure implements a user-fee agreement issued in January 2007 as well as a similar user-fee plan for medical devices. It also continues incentives for sponsors to study pediatric uses of drugs and devices and gives FDA authority to require postapproval studies. Manufacturers will have to disclose more information about ongoing clinical trials and research results and must revise product labels within a set time frame. There is more funding for FDA oversight of postmarket drug use and for agency information systems. And manufacturers of more risky medications will have to adopt a range of pharmacovigilance activities to ensure appropriate product use.
Jul 30, 2007
Pharmaceutical Executive
Twelve years is probably "the best deal the industry is going to get," comments former FDA official Scott Gottlieb. "This is a genuine compromise."
Jun 01, 2007
Pharmaceutical Executive
The danger is that effectiveness studies could be used to limit coverage to low-cost products and that additional research requirements for sponsors could be costly
May 01, 2007
Pharmaceutical Executive
The push is on to establish an approval pathway for generic versions of biotech therapies. The Hatch-Waxman Act of 1984 established a process whereby generic-drug manufacturers could obtain approval for a product based on the innovator company's data. But Hatch-Waxman doesn't apply to biologics regulated by the Public Health Service Act, and generics makers—as well as some Big Pharma companies and small biotech firms—want Congress to give the Food and Drug Administration authority to set up a similar process for these products as well.
Mar 01, 2007
Pharmaceutical Executive
Critics asked for a reevaluation of new drugs a year after launch. FDA's plan to issue report cards on new drugs responds to that demand—but not completely.
Feb 01, 2007
Pharmaceutical Executive
Democrats want more transparency from pharma, and Republicans also are making noise about pricing. But government drug reimbursement is hard to get right and often creates perverse patient care incentives.
Nov 01, 2006
Pharmaceutical Executive
Long turnaround on ad reviews adds new complications to the process of developing marketing plans.
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