The U.S. Patent and Trademark Office has resisted researchers' overreaching in their patenting of genes, and researchers' work is seldom compromised by patents.
There are good reasons for the European Union to worry about the health of its pharmaceutical firms, but fortunately there are things it can improve.
Democrats have made clear that the lifesaving drug industry will soon face politically inspired assaults.
The Supreme Court's Wyeth decision will hurt new drug development and limit physicians' willingness to use certain drugs.
The Supreme Court's decision in Wyeth v. Levine will be negative for patient welfare.
Maurice Hilleman's remarkable period of industrial scientific research yielded the most cost-effective medicines ever made.
AEI Online
January 21, 2009
President Obama's FDA commissioner should avoid actions that make the drug development process more costly and inefficient.
Obama's FDA commissioner should avoid actions that make the drug development process more costly and inefficient.
AEI Online
December 8, 2008
Congress should act in protecting patents for follow-on biologics, relying on a few basic principles that do not suppress research and developmentin this vital sector.
AEI Online
November 3, 2008
The Supreme Court's decision in Wyeth v. Levine could lead the FDA to require excessive warnings on medications and impose "contraindications" that would constrain medical practice.
AEI Online
September 23, 2008
Regardless of the intentions, clinical drug trials driven primarily by marketing yield enormous benefits for patients and practitioners.
Marketing-driven clinical pharmaceutical trial intend to increase sales and profits but also yield enormous benefits for patients.
New efforts to undermine the country's drug development system are cause for worry.
The FDA's restrictive approach toward new drugs, supported by Senator Ted Kennedy, comes at the expense of many patients and possibly Kennedy, too.
The FDA's restrictive approach toward new drugs, supported by Senator Ted Kennedy,comes at the expense of many patients and possiblyKennedy, too.
The U.S. Supreme Court recieved an amicus brief on FDA regulation.
The commonly held view that state tort liability litigation can do much good and little harm because it provides added protection to patients and consumers is largely unsupported.
Testimony in defense of the FDA, which has come under attack recently for its handling of drug safety.
The U.S. patent system is more important than ever. It is also a mess, but help may finally be on the way.
It is better to require oncologist members of reimbursement committees to ponder trade-offs than to allow those trade-offs to languish in obscurity.
Government should address intellectual property reform carefully and with caution.
Government should address intellectual property reform carefully and with caution.
Doesprescription drug advertisinginduce excess or danger inprescribing practices?
AEI Online
September 26, 2007
The FDAAmendments Act of 2007 will bring the most important changes in FDA regulation in at least a decade, but it is an unnecessary law.
In patent politics there is more at stake than money.
Scholars offer considerations for the reauthorization of the State Children's Health Insurance Program.
DePaul Journal of Health Care Law
May 1, 2007
Strong property rightsand minimal interference will ensuretheefficiency and success of the pharmaceutical industry.
AEI Online
April 24, 2007
Follow-on biologics are not like ordinary generics, and therefore require Congress to exercise a deft regulatory hand.
The FDA's recent move was a giant step toward a calamitous new drug approval policy.
Innovation in drugs and medical devices in the U.S. is rampant.
A surprising new study on heart disease treatments will not just change medicine--it will help shape basic science.
Congress has pushed the FDA too far with its new rules.
AEI Online
March 16, 2007
Looming on the horizon is a political battle over direct-to-consumer advertising of prescription drugs.
Many people love to hate direct-to-consumer advertising, but research suggests the ads do more good than harm.
An amicus brief regarding Abigail Alliance v. FDA.
At a time when cancer, Alzheimer's, and other vicious diseases would benefit most from technological advances, a new law may attempt to stifle innovation.
Attempts to abolish conflicts of interest in the FDAcould tie the organization'shands as it goes about the crucial task of marshalling the best scientific advice.
Derived partly from his own research and analysis,Richard Epstein summarizes an immense literature while digging into knotty issues in the pharmaceutical industry.
Targeted biotech drugs that attack specific biological molecules that cause disease are bringing new benefitsand fomentingpricing dynamics different from those of traditional drugs.
The FDA needs to know what patients want, and it should give those preferences very great weight.
It's time for Plan C. Clinton and her allies should let the Senate vote on the von Eschenbach nomination.
This piece reviews earlier work on international pharmaceutical prices and then brings to bear a data set that permits us to explore questions not previously addressed.
ANew Jersey jury awarded compensationto John McDarby, 77,who sued Merck after suffering a heart attack while taking the pain reliever Vioxx.
AEI Online
March 28, 2006
With the fates of the Food and Drug Administration and the pharmaceutical industry more intertwined than ever, our health depends on regulatory innovation as much as on scientific progress.
A study regarding Multiple Sclerosis patients' attitudes about the risks and benefits of drug therapy.
What are the odds of another pandemic--this time, bird flu--happening?
AEI Online
February 10, 2006
A new Food and Drug Administration labeling rule could provide better information to consumers and prevent hyperactive litigation.
How severe is the crisis in the pharmaceutical industry?
How will new prescription label requirements affect pharmaceutical companies?
While the world stands transfixed by the specter of a pandemic flu, a very different threat, bioterrorism, remains largely unaddressed.
Two recent books, Marcia Angell's The Truth About Drug Companies and Jerome Kassirer's On the Take are often grouped with other anti-pharmaceutical-industry tracts.
New York Sun
October 18, 2005
The best way to confront a brand new flu bug is to avoid being swept by hysteria into serious policy mistakes.
AEI Online
September 30, 2005
New research findings and a thorough reassessment of older research indicate that drugs like Vioxx can have many important benefits and great potential for addressing serious problems.
Verdicts like the one against Vioxx could end up denying valuable new drugs to patients.
AEI Online
September 1, 2005
The recent verdict in a case involving the pain reliever Vioxx demonstrates how junk science can corrupt drug litigation.
New York Sun
August 22, 2005
The American tort liability systemworks badly when it gets infected by junk science.
If the anti-tobacco community really thinks higher prices are good for smokers, it shouldwork on passinga tax law instead of squiggling past Congress by bringing lawsuits.
Government reimbursement programs often create cross-subsidies and other distortions that greatly complicate the task of setting reasonable and efficient reimbursement levels.
This is a study of international disparities in prescription drug prices between the United States and five OECD nations (Australia, Canada, France, Germany, and the U.K.).
Post-approval drug safety surveillance is an extraordinarily difficult task.The Vioxx episode has probably made it more difficult for the Food and Drug Administration to do its job.
Want to get people to quit smoking? Give them more ways to get nicotine.
AEI Online
April 14, 2005
Two scholars speak out on drug importation.
Prepared for a Conference on Consumers, Information, and the Evolving Healthcare Market Place
April 6, 2005
An examination of Cox-2 class drugs for assessing Merck's decision to withdraw Vioxx.
Tech Central Station
March 30, 2005
Congress should just let the Food and Drug Administration get on with its job.
Chemical and Engineering News
January 31, 2005
John Calfee reviews Marcia Angell's book The Truth about the Drug Companies: How They Deceive Us and What to Do about It.
We have a pharmaceutical research and development system that really works.
AEI Online
November 1, 2004
Legislators should adopt policies that encourage companies to make vaccines more quickly and less expensively.
Journal of Public Policy and Marketing
October 1, 2004
Adoption of a stakeholder approach is likely to undermine essentialresearch and developmentwhile doing little to curtail the HIV/AIDS epidemic.
California Connected/radio station KQED
August 26, 2004
John E. Calfee and Merrill Goozner debate the question of how much the government can and should do about the cost of medicines, now and in the future.
Nature Magazine
June 1, 2004
Review of The $800 Million Pill: The Truth behind the Cost of New Drugs by Merrill Goozner.
International Journal of Advertising
May 27, 2004
The authors examine direct-to-consumer advertising in the United States and New Zealand,the New Zealand self-regulatory model, and consumer survey results from both countries.
Senate Committee on Finance; Joint Committee on International Trade and Health
April 27, 2004
Price controls that keep the price of pharmaceuticals below market levels impede access to drugs, discourage drug development, and allow other countries to free-ride on American R&D.
Washington Legal Foundation
March 24, 2004
The current wave of alcoholic beverage litigation is part of a larger trend toward regulation by litigation and will probably fail.
Testimony before the House Committee on Industrial Relations for the State of Georgia on the harmful effects of a bill to enact comprehensive pharmaceutical price controls.
AEI Online
January 1, 2004
Through the Medicare Act of 2003, private plans will offer more services to seniors, but with restrictions that could blunt the effectiveness of competition in restraining cost growth.
AEI Online
November 1, 2003
Pressureis buildingto give Americans access to prescription drugs from price-controlled nations, yet legislation needs to consider the effects of allowing unrestricted importation.
The Weekly Standard
July 21, 2003
The House is tempted by a terrible idea.
Reimportating drugs would mean importing foreign price controls, which would have disastrous consequences for future drug research and development.
Health Affairs
February 26, 2003
The emerging evidence on DTC advertising is consistent with a larger pattern in which marketing has been found to increase consumer welfare.
Washington Times
January 28, 2003
A fusillade of criticism has fallen upon the United States for being the lone holdout in a WTO proposal to encourage poor nations to import generic versions of patented drugs.
Consumers' Research
November 1, 2002
Consumers should understand how reimportation would work if it were actually put in place, because it would be a classic example of unintended consequences.
Journal of Public Policy and Marketing
September 23, 2002
Little is known about the effects of DTC advertising, especially its impact on consumer behavior (as opposed to attitudes and knowledge) and, ultimately, on consumer health.
Saint Paul Pioneer Press
September 22, 2002
Drugs are cheaper in Canada than in the United States, leading the Senate to back a bill that would allow the reimportation of U.S.-made drugs from Canada.
Testimony before the Food and Drug Administration on September 13, 2002, on how the FDA can assure that its controls over commercial speech conforms to Supreme Court decisions.
BCBSHealthIssues.com
August 1, 2002
The Charlotte Observer
March 17, 2002
Studies show that drug advertising actually saves consumers money by alerting them to the benefits of new medicines that prolong and enhance life and reduce hospital stays.
What are the economic barriers to bioterrirism vaccine development and distribution and the problem of liability exposure?
Consumers' Research Magazine
November 1, 2001
Recent events have changed bioterrorism from a theoretical threat into an immediate one; weneed tools for dealing with bioterrorism when it occurs.
AEI Online
October 31, 2001
We need tools for dealing with bioterrorism when it occurs, and among these tools are pharmaceuticals.
Residence of the American Ambassador to Germany
October 11, 2001
Germany will be an observer and a consumer of the fruits of the pharmaceutical revolution, but it will not be one of its leaders.
Senate Subcommittee on Consumer Affairs, Foreign Commerce, and Tourism
July 19, 2001
Direct-to-consumeradvertising appears to make patients more comfortable with the risks and benefits of the medicines they take.
Annals of Internal Medicine
June 5, 2001
Pharmaceutical price controls offer short-term gains for a small proportion of patients at the cost of curtailing research that promises to bring far better therapies in the future.
Foreign Affairs.
January 2, 2001
Price controls persist because health agencies can benefit from a system that reliably protects profits and discourages new entrants while assuring stability in prices and expenditures.
Journal of Public Policy & Marketing
October 1, 2000
When R. J. Reynolds brought its Joe Camel cartoon character from France in 1988 for use in the United States, it launched a controversy that outlived the character itself.
Sacramento Bee
July 6, 2000
Rather than latching onto the folly of other nations, we should be urging Canada and European nations to dismantle their own drug-price controls.
Knight Ridder/Tribune
July 4, 2000
Rather than latching onto the folly of other nations, we should be urging Canada and European nations to dismantle their own drug-price controls.
World Health Organization
May 30, 2000
The WHO can usefully focus on two things: supporting a shift in attitudes and leadership, especially in the health care community; and permitting the marketplace to make tobacco use safer.
Consumer's Research Magazine
May 1, 2000
Pharmaceutical costs have aroused controversy for decades, but debate has intensified over the past year.
White Hous plans offer hope for a Medicare drug benefit that would permit the pharmaceutical research revolution to continueand introducingmore life-saving and life-improving therapies.
Wall Street Journal
July 22, 1999
It would be too easy, in an effort to cut costs, to constrict the pipeline that is producing one new wonder drug after another.
Bill Clinton's proposed drug benefit for Medicare recipients is predicated on driving down the cost of drugs that elderly Americans need.
AEI Online
February 8, 1999
Fixing drug prices at lower levels would inevitably curtail development and distribution of new products that improve and extend life.
The time has come for Congress to act on the asbestos litigation.
Los Angeles Times
August 2, 1998
While tobacco liability continues to occupy Congress, another liability issue has bedeviled the courts and tortured victims for many years.
Weekly Standard
July 20, 1998
Legal Times
July 20, 1998
It is time for Congress to act on the litigation problems caused by asbestos cases.
The campaign to reduce smoking by attacking the tobacco industry rather than the habits of individual smokers will not succeed.
Consumers' Research Magazine
April 1, 1998
A great truth about advertising is that it is a tool for communicating information and shaping markets.
AEI and the American Cancer Society
September 12, 1997
On July 21, 1997,AEI and the American Cancer Societyreleased the results of a telephone survey of a representative sample of 200 practicing oncologists such as cancer specialists.
In light of the current debate over the regulation of cigarettes, this piece concerning the consequences of limiting tobacco advertising is particularly relevant.
Legal Times
February 10, 1997
Class action settlements avoid the mammoth costs and delay of individual lawsuits or traditional class action litigation.
One must face the fact that litigation is no substitute for mass settlements, nor is it a rational and humane method for compensation.
Legal Intelligencer
October 16, 1996
If the Supreme Court decides to take the Georginecase, it can allow the legal system to retrieve a semblance of justice from what a deplorable exercise in using injured plaintiffs.
Wall Street Journal
October 1, 1996
Journal of Public Policy and Marketing
October 1, 1996
It is important tomake an independent assessment of the likely effects of proposed advertising bans and other interventions in informational competition.
Advertising Age
September 16, 1996
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