Apr 1, 2008
By:
Jill Wechsler
International outsourcing carries risks for marketers and regulatory challenges for FDA
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Congress is firing plenty of ammunition at pharma companies—and the regulators
Mar 1, 2008
By:
Jill Wechsler
Congress is firing plenty of ammunition at pharma companies—and the regulators
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Congress blocks DTC user fees, Reagan-Udall, and field force reforms while granting a slight
Feb 1, 2008
By:
Jill Wechsler
Congress blocked DTC user fees, Reagan-Udall, field force reforms while slightly bumping FDA's budget
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Pricing, safety, comparative effectiveness, patents, and biosimilars top 2008's policy agenda
Jan 1, 2008
By:
Jill Wechsler
Pricing, safety, comparative effectiveness, patents, and biosimilars top 2008's policy agenda
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Drugs targeted to select patients may justify high prices, reduce safety problems, and improve care
Dec 1, 2007
By:
Jill Wechsler
The ultimate goal is for the medical system to develop new evidence as a natural by-product of delivering appropriate care
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FDAAA aims to restore public trust in drug safety regulation but may curb investment in R&D
Nov 1, 2007
By:
Jill Wechsler
FDAAA aims to restore public trust in drug safety regulation but may curb investment in R&D
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The prescription drug plan brings affordable benefits to millions, along with increasing scrutiny of costs
Oct 1, 2007
By:
Jill Wechsler
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").
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FDA legislation to boost user fees even more to support new testing and disclosure requirements
Sep 1, 2007
By:
Jill Wechsler
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.
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A new pathway for follow-on biologics relies on data exclusivity to shield innovators from early competition
Jul 30, 2007
By:
Jill Wechsler
Twelve years is probably "the best deal the industry is going to get," comments former FDA official Scott Gottlieb. "This is a genuine compromise."
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