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Category: FDA Regulation
The time and costs required to bring new medical products to market is growing ever larger. Today, it may take more than a decade and hundreds of millions
of dollars to bring a single new medical product innovation to the public from initial conception to FDA approval. The slow pace and high cost of
development contributes to the cost of health care and delays patient access to potentially lifesaving innovations.
At the same time, the FDA is facing a crisis in confidence among consumers, media and policymakers, with some critics declaring the agency
“broken”—unable to ensure that medical products offered for sale in the U.S. are reasonably safe and effective. Doctors and academic medical
centers, too, face growing concerns about allegedly harmful interactions with industry during the development and marketing of medical products.
The result is a growing call for sweeping new regulation of the industry at both the state and federal levels.
Advances in the postmarket monitoring of new products along with new molecular and genetic tools for the detection and treatment of disease have
the potential to revolutionize the regulation of new and existing medical products, making health care more predictive and preventive rather
than empirical and reactive—thus improving patient outcomes and potentially reducing health care costs.
Unfortunately, in our zeal to reduce risks, regulate potential conflicts, and mandate transparency, we may reduce incentives for
companies to develop and market improved products due to increased tort litigation; inhibit doctors from collaborating with companies
in designing safer and more effective products; and slow the FDA’s efforts to bring its oversight activities into conformity with the
latest scientific and technical advances.
[Spotlight] [Commentary] [Research] [Events] [News]
Spotlight
Commentary
- Push for more domestic clinical trials may hurt patients, Anup Malani and Tomas J. Philipson, Washington Examiner, 7-21-10
- Avandia Advice: Talk to Your Doctor. (But What About?), Katherine Hobson, Wall Street Journal, 7-16-10
- Diet Drug Qnexa Gets Thumbs-Down In Avandia's Wake, Scott Hensley, NPR's "Health Shots," 7-16-10
- Avandia on Trial, Editorial, Wall Street Journal, 7-16-10
- Avandia, Qnexa Mean a Big Week for FDA Advisory Committee, Katherine Hobson, Wall Street Journal, 7-12-10
- Making the FDA More Patient-Friendly, David Gratzer, FrumForum, 6-16-10
- Study Calculates Value of Time Lost in FDA Approval Process, Ryan Davison, Research!America, 6-16-10
- FDA is slowing down necessary drugs and treatments, Paul Howard, Washington Examiner, 6-16-10
- No Refills, Megan McArdle, The Atlantic, July/August 2010
- The FDA and Methuselah, Peter Huber, Forbes, 3-25-10
- A Long And Deadly Wait, Matthew Herper, Forbes.com, 10-1-09
- The FDA Rejects Another Good Cancer Drug, Matt Alsante, Wall Street Journal, 9-24-09
- F.D.A.'s Secret Files, New York Times editorial, 6-3-09
- 'Caution Syndrome' Infects The FDA, David Gratzer, Forbes.com, 5-22-09
- How To Maintain FDA Standards, Bruce Gingles and Thomas P. Stossel, Forbes.com, 4-29-09
- Prostate Cancer and FDA Politics, Wall Street Journal editorial, 4-20-09
- More Populism At The FDA?, Richard Epstein, Forbes.com, 4-14-09
- FDA Faces Tough Choice On New Diabetes Drug, Robert Langreth, Forbes
- Charting a new course at the FDA, Marcia Angell, Boston Globe, 4-7-09
- House lights up FDA regulation, Jeff Stier, Washington Times, 4-6-09
- Strong Leadership for the F.D.A., New York Times, 3-17-09
- The wrong way to fix the FDA, Jeff Stier and Henry Miller, The Guardian, 3-15-09
- The Future Of The FDA, Tevi Troy, Forbes.com, 3-16-09
- Drug Regulators in the Jury Box, Michael Kinsley, Washington Post, 3-13-09
- The Supreme Court and the Tyranny of Lawyers, L. Gordon Crovitz, Wall Street Journal, 3-9-09
- A 'cure' worse than gangrene, James Copland and Paul Howard, Washington Times, 3-9-09
- Wyeth's Strategic Loss, Forbes, 3-5-09
- Pre-empting Drug Innovation, Wall Street Journal, 3-5-09
- Regulation in the Era of Globalization, Roger Bate and Karen Porter, The American, 2-27-09
- THE DEADLY TOLL OF VACCINE HYSTERIA, Scott Gotleib, New York Post, 2-16-09
- ABA policy could be horrible medicine, Quin Hillyer, Washington Examiner, 2-10-09
- FDA must shift priorities, Scott Gottlieb, USA Today, 2-11-09
- Time for a fresh start for the FDA, Financial Times editorial, 1-11-09
- The right prescription for drug safety, Paul Howard and Marie Gryphon, 12-4-08
Research
- Cost of Caution: The Impact on Patients of Delayed Drug Approvals, Tomas J. Philipson and Eric Sun, the Manhattan Institute's Project FDA, 6-14-10
- The Effects of Product Liability Exemption in the Presence of the FDA, Tomas Philipson, Eric C. Sun and Dana Goldman, Econ Papers, 1-6-10
- Killing Americans by Stifling Medical Innovation: The Medical Device "Safety" Act of 2009, Hans A. von Spakovsky, The Heritage Foundation, 8-4-09
- Factors Associated With Multiple FDA Review Cycles and Approval Phase Times, Joseph DiMasi and Laura Fadan, Drug Information Journal
- In the Wake of Wyeth v. Levine: Making the Case for FDA Preemption and Administrative Compensation, James R. Copland and Paul Howard, The Manhattan Institute, 3-9-09
News
- Sanofi sues to stop generic drug's sale, Boston Globe, 7-28-10
- China Never Investigated Tainted Heparin, Says Probe, Wall Street Journal, 7-22-10
- FDA orders halt in enrollment in clinical trial for diabetes drug Avandia, Boston Globe's "White Coat Notes," 7-21-10
- F.D.A. Panel Urges Limits for Avastin, New York Times, 7-21-10
- FDA Questions Avastin's Use in Breast Cancer, Wall Street Journal, 7-16-10
- F.D.A. Panel Votes Against Obesity Drug, New York Times, 7-16-10
- FDA panel's vote on Avandia reveals mixed opinions on diabetes drug's safety, Washington Post, 7-15-10
- FDA Panel Backs Keeping Avandia on the Market, Wall Street Journal, 7-14-10
- Panel to Rule on Safety of Diabetes Drug, New York Times, 7-14-10
- Diabetes Drug Maker Hid Test Data on Risks, Files Indicate, New York Times, 7-13-10
- Grassley Says Glaxo Withheld Drug Data, Wall Street Journal, 7-13-10
- New Diet Drugs Must Pass Unique Test, Wall Street Journal, 7-12-10
- 2nd UPDATE: Roche Files Novel Cancer Drug For Approval, Wall Street Journal, 7-7-10
- Federal judge rules for Merck in state Vioxx suit, Associated Press, 6-29-10
- Two New Studies Cite Heart Risk in Glaxo's Avandia, Wall Street Journal, 6-29-10
- Diabetes Drug Poses Safety Test For FDA, NPR, 6-29-10
- FDA to alter rules on devices, Boston Globe, 6-23-10
- Concern Over Foreign Trials for Drugs Sold in U.S., New York Times, 6-22-10
- Torrid Agenda For FDA Advisory Committees In July, The RPM Report, 6-4-10
- FDA eyes overhaul for medical device approvals, Associated Press, 2-17-10
- F.D.A. to Increase Oversight of Medical Radiation, New York Times, 2-10-10
- FDA fails checkup on drug effectiveness, Washington Times, 10-26-09
- Drug Agency May Reveal More Data on Actions, New York Times, 6-2-09
- Hamburg to Take Hold of FDA, Pharmaceutical Technology, 5-21-09
- Senators Offer Their Support to F.D.A. Nominee, New York Times, 5-8-09
- Will the FDA Kill Adult Stem Cell Medicine?, H Plus Magazine, 5-1-09
- F.D.A. to Seek New Proof for Old Medical Devices, New York Times, 4-8-09
- Hamburg, Pick for FDA, Faces an Agency in Crisis, Wall Street Journal, 3-17-09
- FDA Pick Was NYC Health Chief, Washington Post, 3-12-09
- Ruling could spur tougher drug warnings, Boston Globe, 3-6-09
- Political Lobbying Drove FDA Process, Wall Street Journal, 3-6-09
- Pre-emption preempted by Justice Thomas, ZD Net, 3-5-09
- Dems Move to End Pre-Emption of Medical-Device Lawsuits, Wall Street Journal Health Blog, 3-5-09
- High Court Eases Way to Liability Lawsuits, Wall Street Journal, 3-5-09
- A Big Day for State Tort Law: A Closer Look at Wyeth v. Levine, WSJ Law Blog, 3-4-09
- The FDA's Infection, Forbes, 3-2-09
- Obama healthcare budget includes FDA reform, Reuters, 2-26-0
- Vaccine book brings out hidden support: author, Reuters, 2-18-09
- Court: Vaccine didn't cause autism, Philadelphia Inquirer, 2-12-09
- Drugmakers push for looser off-label rules, San Francisco Chronicle, 5-2-08
- FDA Wants More Clues from Merck, Newark Star-Ledger, 5-1-08
- FDA Identifies First Steps in Requirements for Safety Plans, FDA News, 3-27-08
- FDA Denies It is Risk Averse on Drugs, Financial Times, 3-26-08
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