Articles by Jill Wechsler - Pharmaceutical Executive

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Articles by Jill Wechsler

Open Season on FDA

Congress is firing plenty of ammunition at pharma companies—and the regulators
Mar 1, 2008

Congress is firing plenty of ammunition at pharma companies—and the regulators

Funding Follies at FDA

Congress blocks DTC user fees, Reagan-Udall, and field force reforms while granting a slight
Feb 1, 2008

Congress blocked DTC user fees, Reagan-Udall, field force reforms while slightly bumping FDA's budget

New Year, New Policy Challenges for Pharma

Pricing, safety, comparative effectiveness, patents, and biosimilars top 2008's policy agenda
Jan 1, 2008

Pricing, safety, comparative effectiveness, patents, and biosimilars top 2008's policy agenda

Getting Personal

Drugs targeted to select patients may justify high prices, reduce safety problems, and improve care
Dec 1, 2007

The ultimate goal is for the medical system to develop new evidence as a natural by-product of delivering appropriate care

More Confidence—or Slower Development?

FDAAA aims to restore public trust in drug safety regulation but may curb investment in R&D
Nov 1, 2007

FDAAA aims to restore public trust in drug safety regulation but may curb investment in R&D

Medicare Part D Puts the Focus on Prices

The prescription drug plan brings affordable benefits to millions, along with increasing scrutiny of costs
Oct 1, 2007

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").

Paying for Safety

FDA legislation to boost user fees even more to support new testing and disclosure requirements
Sep 1, 2007

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.

Exclusivity vs. Patents

A new pathway for follow-on biologics relies on data exclusivity to shield innovators from early competition
Jul 30, 2007

Twelve years is probably "the best deal the industry is going to get," comments former FDA official Scott Gottlieb. "This is a genuine compromise."

Washington Report: Vaccines for Everyone

New vaccines can be good business and a huge boon to public health. But the challenge is to establish prices that ensure global access.
Jul 3, 2007

Not long ago, vaccines were Big Pharma's neglected stepchild—cheap, one-time treatments that scarcely made a profit. The pharmaceutical industry was moving away from them in a hurry.

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