How to Think about Patenting Genes

A recent court decision has been widely applauded as a pathway to abolishing human gene patents. But a closer look shows that getting rid of gene patents would probably be a big mistake.

Something Old, Something New: Biotech's Enormous Potential

Medical breakthroughs from using existing drugs in new ways await discovery--if manufacturers have an incentive to pursue them.

Pricing Out Private Insurance

What comes next for private health insurance? Beginning later this year, ObamaCare will create extraordinary new pressures on the insurance industry.

Reform through Reconciliation--Worse than Imagined

As with the run-up to the Senate health care bill, we are again paying the cost of haste. Far too little attention is being given to crucial matters.

Seniors Feeling the Squeeze: Rising Drug Prices and the Part D Program

Drug prices have recently become less expensive with the spread of generic versions, but Medicaid support seems to make drugs more expensive.

Obama's Misleading Assault on the Insurance Industry

President Obama knows better than his demagoguery suggests when it comes to the insurance industry.

The Facts versus the Grandstanding

Repeating the erroneous belief that reform for health care cannot make things worse is the weakest foundation for any major legislation.

H.R. 4489, the FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act

H.R. 4489 focuses on a specific market: prescription drug coverage for federal employees; the legislation would impose a wide variety of restrictions, controls, and mandates.

Conflict of Interest

The new Partners HealthCare conflict-of-interest policy does nothing address the timeless and persuasive conflict of interest between physician and provider.

Six Ways Not to Reform Health Care

Congress has made many mistakes in constructing its proposals for health care reform.

Stop Taking R&D for Granted

If the conditions that foster medical technology research and development remain in place, future advances will probably dwarf what we have already seen, but health reform legislation in Congress has almost completely ignored the importance of protecting research and development.

We Already Know Why Health Care Overhaul Will Fail

The health care overhaul is shaping up as the highest-risk legislation in modern times.

Drug Development in the Balance

There are good reasons to worry about the prospect of adding drug reimportation provisions to health care overhaul legislation.

Limiting Drug Prices Means Limiting Future Cures

Controls would take away the industry's incentive to develop new lifesaving medications and therapies.

What Do Vitamins and Fish Oil Tell Us about Drug Research?

There is a second world of drug research, a world in which patents do not exist and for-profit research is permanently moribund. Its history should stop "reformers" in their tracks.

The Dangers of Fannie Mae Health Care

A public health care plan would have certain advantages. That's precisely the problem.

A Public Health Disaster in the Making

Congress is poised to pass one of the worst public health laws ever conceived.

And Now, a Few Words about Antivirals for Pandemic Flu

The development of antivirals for pandemic flu provides important insights into the pharmaceutical industry's ability to advance public health.

Decoding the Use of Gene Patents

The U.S. Patent and Trademark Office has resisted researchers' overreaching in their patenting of genes, and researchers' work is seldom compromised by patents.

What Can the European Union Do to Sharpen Its Innovative Edge in Pharmaceuticals?

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.

Learning a Little about Drug Companies from The Lancet

Democrats have made clear that the lifesaving drug industry will soon face politically inspired assaults.

The Supreme Court's Wyeth Blunder

The Supreme Court's Wyeth decision will hurt new drug development and limit physicians' willingness to use certain drugs.

A Troubling Supreme Judgment

The Supreme Court's decision in Wyeth v. Levine will be negative for patient welfare.

Medicine's Miracle Man

Maurice Hilleman's remarkable period of industrial scientific research yielded the most cost-effective medicines ever made.

Tough Challenges at the FDA

President Obama's FDA commissioner should avoid actions that make the drug development process more costly and inefficient.

Tough Challenges at the FDA

Obama's FDA commissioner should avoid actions that make the drug development process more costly and inefficient.

When Patents Are Not Enough

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.

FDA Preemption and Patient Welfare in Wyeth v. Levine

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.

Seeding Sales and Science

Regardless of the intentions, clinical drug trials driven primarily by marketing yield enormous benefits for patients and practitioners.

Seeding Sales and Science

Marketing-driven clinical pharmaceutical trial intend to increase sales and profits but also yield enormous benefits for patients.

The Indispensable Industry

New efforts to undermine the country's drug development system are cause for worry.

Drugs Kennedy Needs

The FDA's restrictive approach toward new drugs, supported by Senator Ted Kennedy, comes at the expense of many patients and possibly Kennedy, too.

Drugs Kennedy Needs

The FDA's restrictive approach toward new drugs, supported by Senator Ted Kennedy,comes at the expense of many patients and possiblyKennedy, too.

Supreme Court Amicus Brief Regarding Wyeth v. Diana Levine

The U.S. Supreme Court recieved an amicus brief on FDA regulation.

FDA Preemption of State Tort Liability Lawsuits on FDA-Regulations Drugs and Devices

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.

FDA Oversight of Drug Safety

Testimony in defense of the FDA, which has come under attack recently for its handling of drug safety.

Patents Pending

The U.S. patent system is more important than ever. It is also a mess, but help may finally be on the way.

Can Quality-Adjusted Life Year Avoidance Help in Oncology Drug Reimbursement Decisions?

It is better to require oncologist members of reimbursement committees to ponder trade-offs than to allow those trade-offs to languish in obscurity.

Congress's Patent Mistakes

Government should address intellectual property reform carefully and with caution.

Congress's Patent Mistakes

Government should address intellectual property reform carefully and with caution.

An Assessment of Direct-to-Consumer Advertising of Prescription Drugs

Doesprescription drug advertisinginduce excess or danger inprescribing practices?

Reform without Reason

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.

Patent Challenges Have Wide Impact on Big Pharma

In patent politics there is more at stake than money.

SCHIP Guidelines: Principles for Health Insurance Coverage for Children and Families

Scholars offer considerations for the reauthorization of the State Children's Health Insurance Program.

Overdose: How Excessive Government Regulation Stifles Pharmaceutical Innovation

Strong property rightsand minimal interference will ensuretheefficiency and success of the pharmaceutical industry.

Facing Reality on Follow-On Biologics

Follow-on biologics are not like ordinary generics, and therefore require Congress to exercise a deft regulatory hand.

FDA Steps Backward

The FDA's recent move was a giant step toward a calamitous new drug approval policy.

The Golden Age of Medical Innovation

Innovation in drugs and medical devices in the U.S. is rampant.

Lessons of the Heart

A surprising new study on heart disease treatments will not just change medicine--it will help shape basic science.

Pushing Too Far

Congress has pushed the FDA too far with its new rules.

The Truth about the Drug Ads

Looming on the horizon is a political battle over direct-to-consumer advertising of prescription drugs.

The Truth about the Drug Ads

Many people love to hate direct-to-consumer advertising, but research suggests the ads do more good than harm.

Regulating Access to Developmental Drugs for Terminally Ill Patients

An amicus brief regarding Abigail Alliance v. FDA.

The Real Dangers of Medicare

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.

FDA Advisory Committees and Conflicts of Interest

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.

Drug Dilemma

Derived partly from his own research and analysis,Richard Epstein summarizes an immense literature while digging into knotty issues in the pharmaceutical industry.

The Emerging Market Dynamics of Targeted Therapeutics

Targeted biotech drugs that attack specific biological molecules that cause disease are bringing new benefitsand fomentingpricing dynamics different from those of traditional drugs.

Patient Power

The FDA needs to know what patients want, and it should give those preferences very great weight.

Who's Aided by Impasse over Vote for FDA Chief?

It's time for Plan C. Clinton and her allies should let the Senate vote on the von Eschenbach nomination.

An Exploratory Analysis of Pharmaceutical Price Disparities and Their Implications among Six Developed Nations

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.

Rein in the Monster

ANew Jersey jury awarded compensationto John McDarby, 77,who sued Merck after suffering a heart attack while taking the pain reliever Vioxx.

Playing Catch-up

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 Representative Survey of M.S. Patients' Attitudes toward the Benefits and Risks of Drug Therapy

A study regarding Multiple Sclerosis patients' attitudes about the risks and benefits of drug therapy.

For the Birds or Sleeping with the Fishes?

What are the odds of another pandemic--this time, bird flu--happening?

Striking a Balance

A new Food and Drug Administration labeling rule could provide better information to consumers and prevent hyperactive litigation.

Innovative Drug Development in the Context of FDA Regulation

How severe is the crisis in the pharmaceutical industry?

Striking a Balance

How will new prescription label requirements affect pharmaceutical companies?

Creating a Thriving Biodefense Marketplace

While the world stands transfixed by the specter of a pandemic flu, a very different threat, bioterrorism, remains largely unaddressed.

The Truth about Drug Companies and "On the Take"

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.

First, Do No Harm

The best way to confront a brand new flu bug is to avoid being swept by hysteria into serious policy mistakes.

The Vioxx Fallout

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.

What the Texas Jury Did to Patients

Verdicts like the one against Vioxx could end up denying valuable new drugs to patients.

Junk Science Reigns

The recent verdict in a case involving the pain reliever Vioxx demonstrates how junk science can corrupt drug litigation.

Junk Science Reigns

The American tort liability systemworks badly when it gets infected by junk science.

To Really Stop Smoking

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.

Medicaid Prescription Drugs

Government reimbursement programs often create cross-subsidies and other distortions that greatly complicate the task of setting reasonable and efficient reimbursement levels.

An Exploratory Analysis of the Determinants of Pharmaceutical Price Disparities among Six Developed Nations

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.).

The Roles of FDA and Pharmaceutical Companies in Ensuring the Safety of Approved Drugs, Like Vioxx

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.

Where There's Smoke

Want to get people to quit smoking? Give them more ways to get nicotine.

A Joint Statement on Drug Importation

Two scholars speak out on drug importation.

The Significance of the Vioxx Withdrawal

An examination of Cox-2 class drugs for assessing Merck's decision to withdraw Vioxx.

Is the FDA Broken?

Congress should just let the Food and Drug Administration get on with its job.

Does Pharma Need a New Prescription?

John Calfee reviews Marcia Angell's book The Truth about the Drug Companies: How They Deceive Us and What to Do about It.

Why We Should Preserve the American System for Pharmaceutical Research and Development

We have a pharmaceutical research and development system that really works.

Putting Markets to Work in Vaccine Manufacturing

Legislators should adopt policies that encourage companies to make vaccines more quickly and less expensively.

Pharmaceuticals and the Worldwide HIV Epidemic

Adoption of a stakeholder approach is likely to undermine essentialresearch and developmentwhile doing little to curtail the HIV/AIDS epidemic.

The Cost of Medicine

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.

Paying for the Pills

Review of The $800 Million Pill: The Truth behind the Cost of New Drugs by Merrill Goozner.

Direct-to-Consumer Advertising of Prescription Medicines in the United States and New Zealand

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.

International Pharmaceutical Pricing

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.

A Critical Look at the New Litigation against Alcoholic Beverage Advertising

The current wave of alcoholic beverage litigation is part of a larger trend toward regulation by litigation and will probably fail.

Pharmaceutical Price Controls

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.

Of Sausage-Making and Medicare

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.

The Grim Economics of Pharmaceutical Importation

Pressureis buildingto give Americans access to prescription drugs from price-controlled nations, yet legislation needs to consider the effects of allowing unrestricted importation.

The High Price of Cheap Drugs

The House is tempted by a terrible idea.

The High Price of Cheap Drugs

Reimportating drugs would mean importing foreign price controls, which would have disastrous consequences for future drug research and development.

What Do We Know about Direct-to-Consumer Advertising of Prescription Drugs?

The emerging evidence on DTC advertising is consistent with a larger pattern in which marketing has been found to increase consumer welfare.

Patently Wrong

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.

Why Drugs from Canada Won't Cut Prices

Consumers should understand how reimportation would work if it were actually put in place, because it would be a classic example of unintended consequences.

Public Policy Issues in Direct-to-Consumer Advertising of Prescription Drugs

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.

Legislation to Allow Reimporting Drugs from Canada Would Raise Prices There Rather Than Lowering Them in the United States

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.

First Amendment Issues

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.

Drug Re-importation from Canada

Drug Ads Should Be Left Alone

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.

National Immunization Program

What are the economic barriers to bioterrirism vaccine development and distribution and the problem of liability exposure?

Pharmaceutical Patents and Public Safety

Recent events have changed bioterrorism from a theoretical threat into an immediate one; weneed tools for dealing with bioterrorism when it occurs.

Bioterrorism and Pharmaceuticals

We need tools for dealing with bioterrorism when it occurs, and among these tools are pharmaceuticals.

What Role Will Germany Have In the Revolution in Medicine?

Germany will be an observer and a consumer of the fruits of the pharmaceutical revolution, but it will not be one of its leaders.

Direct-to-Consumer Advertising of Prescription Drugs

Direct-to-consumeradvertising appears to make patients more comfortable with the risks and benefits of the medicines they take.

Pharmaceutical Price Controls and Patient Welfare

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.

The Unintended Consequences of Price Controls

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.

The Historical Significance of Joe Camel

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.

Be Wary of Drug-Price Controls

Rather than latching onto the folly of other nations, we should be urging Canada and European nations to dismantle their own drug-price controls.

Bills to Equalize Rx Drug Prices in Unites States and Canada Show Crackpot Economics Is Alive and Well

Rather than latching onto the folly of other nations, we should be urging Canada and European nations to dismantle their own drug-price controls.

Comments to the World Health Organization

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.

Drugs, Drug Prices, and Your Health

Pharmaceutical costs have aroused controversy for decades, but debate has intensified over the past year.

Hearing on Seniors' Access to Prescription-Drug Benefits

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.

Price Controls Are a Prescription for Disaster

It would be too easy, in an effort to cut costs, to constrict the pipeline that is producing one new wonder drug after another.

Pharmaceutical Price Controls Are a Prescription for Disaster

Bill Clinton's proposed drug benefit for Medicare recipients is predicated on driving down the cost of drugs that elderly Americans need.

Why Pharmaceutical Price Controls Are Bad for Patients

Fixing drug prices at lower levels would inevitably curtail development and distribution of new products that improve and extend life.

Healing a National Case of Asbestosis

The time has come for Congress to act on the asbestos litigation.

A Legal Nightmare for Asbestos' Real Victims

While tobacco liability continues to occupy Congress, another liability issue has bedeviled the courts and tortured victims for many years.

Why the War on Tobacco Will Fail

The Litigation Logjam We Can Clear

It is time for Congress to act on the litigation problems caused by asbestos cases.

Why the War on Tobacco Will Fail

The campaign to reduce smoking by attacking the tobacco industry rather than the habits of individual smokers will not succeed.

How Advertising Informs to Our Benefit

A great truth about advertising is that it is a tool for communicating information and shaping markets.

A Representative National Survey of Oncologists FDA on Off-Label Prescribing and Policies toward Information Dissemination

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.

The Ghost of Cigarette Advertising Past

In light of the current debate over the regulation of cigarettes, this piece concerning the consequences of limiting tobacco advertising is particularly relevant.

Efficiency Begets Fairness

Class action settlements avoid the mammoth costs and delay of individual lawsuits or traditional class action litigation.

Solving the Asbestos Litigation Morass

One must face the fact that litigation is no substitute for mass settlements, nor is it a rational and humane method for compensation.

Discussion on the Economics of the Georgine Settlement

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.

FDA

The Industry Effects of Information and Regulation in the Cigarette Market

It is important tomake an independent assessment of the likely effects of proposed advertising bans and other interventions in informational competition.

Smoking Alternatives

Fear of Persuasion

This book addresses the most prominent policy issues raised by advertising--competition, consumer information, children, ad bans, and free speech.