As an agency that responds to Congress rather than to patients, the FDA faces an inherent information problem that inevitably leads to unnecessary patient suffering and death. Though Type I and Type II errors can be equally dangerous, Table 1 illustrates a very important difference from the FDA’s perspective. The political system penalizes FDA officials when a patient dies from a harmful drug the officials approved (Type I error). It far less often penalizes agency officials when a patient dies because they blocked or discouraged the development of a beneficial drug (Type II error).
- Type I errors bring swift and certain retribution down on agency officials. The victims are easily identifiable. Patients and the public can easily trace the victims’ injuries to the FDA’s decision. The victims, their loved ones, the media, and Congress can hold FDA officials to account for approving a harmful product. Importantly, FDA officials know Type I errors lead to congressional hearings, public disgrace, and possibly the end of their careers.
- Type II errors bring almost no consequences for FDA officials. Even though delaying or blocking beneficial drugs can harm patients as much as approving unsafe drugs can, it is typically impossible to hold FDA officials to account for Type II errors. Victims of Type II errors are much harder to identify. It appears the disease, not the FDA, killed them. Typically, neither the victims, nor their loved ones, nor FDA officials can identify which patients an unapproved but beneficial drug might have helped. Victims and their families may never have heard of the drug, perhaps because the high cost of avoiding Type I errors deterred companies from ever developing it.
As a result of this fundamental information asymmetry, the political system can discipline FDA officials only when their decisions cause patients to suffer or die from Type I errors. It effectively cannot discipline FDA officials when their decisions cause patients to suffer and die from Type II errors. Dr. Henry Miller, a former FDA official, describes how this information asymmetry affects the decisions of FDA officials:
In the early 1980s, when I headed the team at the FDA that was reviewing the [new drug application] for recombinant human insulin, the first drug made with gene-splicing techniques, we were ready to recommend approval a mere four months after the application was submitted (at a time when the average time for [new drug application] review was more than two and a half years).… My supervisor refused to sign off on the approval—even though he agreed that the data provided compelling evidence of the drug’s safety and effectiveness. “If anything goes wrong,” he argued, “think how bad it will look that we approved the drug so quickly.”… The supervisor was more concerned with not looking bad in case of an unforeseen mishap than with getting an important new product to patients who needed it.
As a result of this information problem and the perverse incentives it creates, the FDA typically tolerates only a 2.5 percent chance of Type I error when determining whether to approve new drugs. Biostatistician Leah Isakov and colleagues estimate that if the agency’s goal is to save lives, it should be much more tolerant of Type I errors. They estimate that for hypertensive disease, the agency should tolerate a 7.6–9.4 percent chance of Type I errors. For cirrhosis of the liver, it should tolerate a 15.3–17.7 percent chance. For pancreatic cancer, it should tolerate as much as a 27.8 percent chance.
Indeed, cost–benefit analyses consistently find that, at the margin, FDA regulation on balance harms patients’ health.
- Economist Mary K. Olson estimates that when additional revenue from user fees enabled the FDA to review drugs more quickly, the health benefits of quicker access to new drugs were roughly 12 times greater than the costs from additional adverse drug reactions. In other words, the FDA was inflicting 12 times as much harm on patients through Type II errors as it was sparing patients by avoiding Type I errors.
- Economist Tomas Philipson and colleagues found that quicker reviews brought significant health benefits but “did not, in fact, have any effect on drug safety.” This finding implies that the FDA will inflict additional deaths due to Type II errors even if doing so produces no reduction in deaths due to Type I errors.
If FDA officials want to promote health, they should regulate less. They should approve new drugs faster and with less evidence of safety and effectiveness.
Unfortunately, this information asymmetry affects more than just the FDA. Despite such research, many in Congress have sought to give the FDA additional powers to reduce Type I errors.
Government-Imposed Prescription Requirements
Congress also empowers the FDA to determine whether consumers must obtain a prescription before accessing certain drugs. Government‐imposed prescription requirements violate the rights of individuals to make their own health decisions. Here again, the agency’s incentives lead it to impose rules that on balance harm rather than protect patients.
The FDA has used its power to impose prescription requirements to steer consumers toward more dangerous drugs. For years, the agency required prescriptions for nonsedating antihistamines while allowing over-the-counter access to sedating antihistamines, a policy that likely caused air- and auto-travel crashes and fatalities. The FDA blocked access to “Plan B” emergency contraception for more than 12 years. FDA-imposed prescription requirements continue to block access to routine‐use oral contraceptives—which are available without prescription in more than 100 countries—and to life‐saving drugs such as naloxone.
Government‐imposed prescription requirements make patients less safe, not more. Economist Sam Peltzman found:
- “Enforcement of prescription regulation increases poisoning mortality by 50 to 100 percent”;
- “No … statistically significant difference in infectious disease mortality between countries that enforce prescription requirements for antibiotics and those that do not”; and
- “[Prescription] regulation did not reduce—indeed, may have increased—poisoning mortality from drug consumption … poisoning mortality is higher, all else remaining the same, in countries that enforce prescription regulation.”
Since “the FDA would instruct firms to remove from their labels any remaining information that might guide lay users of prescription drugs,” economist Peter Temin argued that government-imposed prescription requirements make consumers more vulnerable to harm by making them more ignorant about health and medicines. “Some part of the gap between the drug knowledge of the average doctor and the average consumer is the product of regulation.” Public health professor Julie Donohue notes this power created “a paradoxical situation … in which potentially dangerous prescription drugs were dispensed to consumers with less accompanying information than [over-the-counter] drugs carried.”
A Better Way of Certifying and Monitoring Drugs and Medical Devices
The FDA’s information problem guarantees that the agency will always value some lives more than others and tolerate unnecessary suffering and death. Fortunately, there is a voluntary, market-based alternative that does not suffer from the FDA’s information problem and that respects the right of patients to make their own medical decisions.
Nobel Prize–winning economist Gary Becker advocated eliminating the FDA’s efficacy standard and returning the FDA to the status quo ante 1962, when the FDA had the power only to block drugs it believed to be unsafe. Peltzman argues that even the safety requirement delivers more harm than benefit. Another Nobel Prize–winning economist, Milton Friedman, proposed eliminating the FDA entirely. As long as a government agency exists whose purpose is to protect patients from harmful drugs, it will always focus disproportionately on Type I errors at the expense of overall patient health.
Congress would do better to eliminate any role for the FDA in certifying the safety and efficacy of drugs or in determining which drugs consumers should need prescriptions to purchase.
Eliminating the FDA would increase patient demand for private certification of safety and efficacy, which currently exists only informally. The threat of liability for harmful products would create powerful incentives for pharmaceutical manufacturers to conduct appropriate testing and seek private certification.
Integrated, prepaid group plans like Kaiser Permanente are uniquely capable of performing safety and efficacy certification. When the FDA wanted to determine whether the pain reliever Vioxx (which it had approved) was causing heart attacks, the agency could not conduct that research itself. It turned to Kaiser Permanente of Northern and Southern California. With liberalization of clinician-licensing laws and reforms that allow consumers to control health spending (see “The Tax Treatment of Health Care” and “Medicare”), additional integrated, prepaid plans could enter the market and offer competing safety and efficacy certifications. Different plans would cater to different risk preferences by applying different approval requirements. Each plan’s reputation for quality (and ability to attract enrollees) would depend on the perceived value of its seal of approval. Unlike the FDA, prepaid group plans could consider cost-effectiveness as a criterion for approval. Unlike the FDA, they could closely monitor drug safety and efficacy after approval and could more quickly detect adverse drug reactions. Patients within or outside such plans would rely on whichever plan’s seal of approval fit their own risk preferences.
Market-based certification would save more lives by striking a better balance between Type I and Type II errors. No one would have the power to force patients to suffer Type II errors. Market-based certification respects the freedom of doctors and patients to make treatment decisions according to individual circumstances.
The first step toward reforming the regulation of drugs and medical devices may therefore be to eliminate the barriers that Congress and state legislatures have erected to integrated, prepaid group plans. (See “Health Insurance Regulation,” “The Tax Treatment of Health Care,” and “Medicare.”)
Concurrently, Congress could allow alternative ways of certifying the safety and efficacy of medical products by granting marketing approval to products approved by other countries’ regulatory bodies.
The next step would be to eliminate either the efficacy standard or the FDA entirely. Either would save lives, on balance, because patients would get quicker access to more beneficial new drugs. While patients would also have quicker access to harmful drugs, at least three factors make that unfortunate effect tolerable. First, more patients would live and thrive thanks to greater innovation and quicker access to helpful drugs than would suffer as a result of harmful drugs. Second, eliminating either the efficacy standard or the FDA itself would lead to greater skepticism of new drugs by doctors and patients. Third, innovations by prepaid group plans and others would more quickly detect and stop adverse drug reactions.
Medical Liability Reform
The right to sue health care providers for medical malpractice is a crucial civil right. Individuals are not free to make their own health decisions if health care providers can impose unwanted costs on patients.
The right to sue for medical malpractice is also an important tool for protecting patients from injury due to negligent care. Patients typically have little information about the quality of care. To the extent that the medical malpractice “system” imposes the costs of negligent care on providers, it encourages providers to take steps to improve quality.
Nevertheless, many people in the United States complain—with some justification—that this system performs poorly. “The medical malpractice system is slow, expensive … stressful to both sides, contentious, prone to error in both directions (i.e., payment for weak claims and nonpayment for strong claims), and perceived by everyone involved as inhumane.” According to one estimate, “it costs $1.33 in overhead to deliver $1 to negligently injured plaintiffs.” Even so, research suggests the system does not do enough to discourage negligent care. Physicians and other providers—who see often-dramatic increases in malpractice insurance premiums—have intermittently declared this system to be in “crisis” for more than 30 years.
Scholars have proposed various reforms. California and Texas have limited the amount patients can recover for noneconomic damages to $250,000 per injury. Other proposals include legislative limits on contingency fees for plaintiffs’ attorneys; “no-fault” compensation systems for medical injuries, such as the limited programs adopted in Florida and Virginia; alternative forms of dispute resolution, such as arbitration and special medical courts; the English rule of costs (“loser pays”); and reform of the collateral source rule.
Each of these reforms would leave some patients better off—typically by reducing prices for medical care—at the cost of leaving other patients worse off. “Loser pays” reforms often reallocate the costs of frivolous lawsuits to the correct party. However, that rule deters less affluent patients from seeking legal redress for legitimate grievances. Limits on contingency fees could expand access to medical care by reducing prices, but at the cost of denying compensation to injured patients whose cases plaintiffs’ attorneys deem too expensive to pursue. Perhaps most important, any reduction in provider liability potentially jeopardizes patient safety by reducing the incentives for providers to avoid negligent care.
In particular, caps on damages could expand access to health care by reducing payouts and liability insurance premiums, but at the cost of leaving some injured patients with uncompensated losses. Damage caps in California and Texas force patients to bear the cost of any noneconomic losses they suffer in excess of $250,000.
Moreover, damage caps do not appear to solve the system’s problems or even deliver on the promises of supporters (disproportionately, physicians) that they will increase physician supply or reduce health care spending. A series of empirical studies on Texas’s damage caps concluded:
Texas’s damage cap dramatically reduced the number of medical malpractice cases and total payouts to plaintiffs, with an especially strong effect on elderly plaintiffs. But Texas’s tort reform package had no discernible, favorable impact on broader measures of health system performance. Health care spending growth did not slow, and physician supply did not increase.… While reform strongly benefited providers, the evidence that it had significant benefits for the broader health care system is simply not there.
Like clinician-licensing regulation, much of what physician groups propose with regard to medical malpractice liability benefits physicians at the expense of patients.
Many Republicans want Congress to enact a nationwide set of limits on malpractice liability. The U.S. Constitution does not authorize Congress to impose substantive rules of tort law on the states. Though the federal government may enact technical procedural changes to tort law, state legislatures are the proper venue for correcting excesses in their civil justice systems. The fact that medical professionals can avoid states with inhospitable civil justice systems gives them significant leverage when advocating state-level medical liability reforms and gives states incentives to enact such reforms. Indeed, many states have.
Though state action is preferable to federal action, state-imposed medical malpractice reforms share two flaws with federal reform. First, imposing on all patients and providers any single set of limits on the right to sue for medical malpractice will help some patients but hurt others. Second, though patients should be free to avoid harmful rules, making any single set of rules mandatory and codifying them in statute makes removing harmful rules extremely difficult.
A more patient-friendly and liberty-enhancing approach would allow patients and providers to write their own medical malpractice reforms into legally enforceable contracts. For cases of ordinary negligence, patients could choose the level of protection they desire, rather than have government impose on them a uniform level of protection (and the accompanying price tag). Providers could offer discounts to patients who agree to limits on compensation in the event of an injury. Patients who don’t agree could pay the higher, nondiscounted price or seek a better deal from another provider. Freedom of contract would thus make medical care more affordable to many low-income patients.
Insurance companies could facilitate such contracts on behalf of their enrollees. Those companies would have strong incentives to ensure that such contracts provide adequate protection; otherwise, the insurers could face higher claims from injured patients who could not collect the full extent of their damages.
Regular tort rules would continue to apply in cases where patients and providers could not or did not contract around them, where patients were subject to duress, or where providers were guilty of intentional wrongdoing or reckless behavior.
Freedom of contract would also enhance quality competition. Providers who invest in processes that avoid patient injuries could offer equivalent or more expansive malpractice protections than their competitors at a lower cost. Low-quality providers would not be able to do the same. They would therefore face strong financial incentives to improve quality.
Such contracts are not possible today because courts have invalidated them as “contracts of adhesion” or “against public policy.” The courts’ refusal to honor those contracts restricts the freedom of adults to make mutually beneficial exchanges that hurt no one else. It also increases the cost of providing medical care to the poor, which has undoubtedly reduced their access to care.
To remedy this undue and costly restriction on liberty, courts should abandon their current policy and enforce contractual limitations on the right to sue for medical malpractice. If courts refuse, state legislatures should require them to do so. Nobel Prize–winning economist Richard Thaler and law professor Cass Sunstein write:
In our view, state lawmakers should think seriously about increasing freedom of contract in the domain of medical malpractice, if only to see whether such experiments would reduce the cost of health care without decreasing its quality. Increasing contractual freedom won’t solve the health care crisis. But it might well help—and in this domain every little bit of help counts.
The medical malpractice system does a poor job of providing relief to injured patients, preventing frivolous lawsuits, or discouraging negligence. The remedies for these shortcomings are not obvious. A dynamic marketplace that allows parties to experiment with—and abandon—different malpractice rules is the quickest and surest way to find those solutions.
Suggested Readings
Black, Bernard S., et al. Medical Malpractice Litigation: How It Works, Why Tort Reform Hasn’t Helped. Washington: Cato Institute, 2021.
Cannon, Michael F. “Health Care’s Future Is So Bright, I Gotta Wear Shades.” Willamette Law Review 51, no. 4 (2015): 559–71.
Epstein, Richard A. “Medical Malpractice: The Case for Contract.” American Bar Foundation Research Journal 87, no. 1 (1976): 87–149.
Friedman, Milton. “Occupational Licensure.” In Capitalism and Freedom. Chicago: University of Chicago Press, 1962, chap. 9.
Singer, Jeffrey A., and Michael F. Cannon. “Drug Reformation: End Government’s Power to Require Prescriptions.” Cato Institute White Paper, October 20, 2020.
Svorny, Shirley. “Could Mandatory Caps on Medical Malpractice Damages Harm Consumers?” Cato Institute Policy Analysis no. 685, October 20, 2011.
———. “Medical Licensing: An Obstacle to Affordable, Quality Care.” Cato Institute Policy Analysis no. 621, September 17, 2008.
Svorny, Shirley, and Michael F. Cannon. “Health Care Workforce Reform: COVID-19 Spotlights Need for Changes to Clinician Licensing.” Cato Institute Policy Analysis no. 899, August 4, 2020.