The Shortage of Generic Sterile Injectable Drugs: Diagnosis and Solutions
According to the U.S. Food and Drug Administration, the number of times drugs were in short supply almost tripled from 61 in 2005 to 178 in 2010. The figure reached more than 250 in 2011. This means that manufacturers reported to the FDA that they were unable to meet demand for the drugs. Hospital and health-system pharmacists, as well as oncologists, anesthesiologists and other specialists have also increasingly reported difficulties acquiring drugs.
These are mostly injectable drugs for cancer and other important therapies, and they are frequently produced by generic drugmakers. These drugs are not dispensed by community pharmacies, but rather administered by health professionals in clinical settings.
Currently proposed solutions are unlikely to address the crisis satisfactorily. Congress appears ready to give more power to the FDA, but making FDA regulations more onerous will not alleviate the current shortage of crucial medicines.
A more promising approach is to make it easier for competitors to enter the market in response to forthcoming shortages. In general, this means reducing and ultimately removing the FDA’s monopoly on the approval of drugs for medical use. Shifting these medicines to Medicare Part D insurance may also stabilize supply by helping ensure manufacturers receive adequate compensation for the medicine, even as taxpayers are protected from escalating costs. … more
These are mostly injectable drugs for cancer and other important therapies, and they are frequently produced by generic drugmakers. These drugs are not dispensed by community pharmacies, but rather administered by health professionals in clinical settings.
Currently proposed solutions are unlikely to address the crisis satisfactorily. Congress appears ready to give more power to the FDA, but making FDA regulations more onerous will not alleviate the current shortage of crucial medicines.
A more promising approach is to make it easier for competitors to enter the market in response to forthcoming shortages. In general, this means reducing and ultimately removing the FDA’s monopoly on the approval of drugs for medical use. Shifting these medicines to Medicare Part D insurance may also stabilize supply by helping ensure manufacturers receive adequate compensation for the medicine, even as taxpayers are protected from escalating costs. … more
Alcohol Control Reform and Public Health and Safety
Michigan regulates the sale of beer, wine and “spirituous” (hard) liquor through state statute and rules promulgated by the Michigan Liquor Control Commission. As part of this system, state government intervenes in the spirituous liquor market as a monopoly wholesaler, a role it has filled since the end of Prohibition. The state also mandates that most suppliers of beer and wine grant exclusive sales territories to a select group of wholesalers. These and other restrictions artificially raise prices and reduce the availability of alcohol to Michigan’s consumers.
Last year, a state Liquor Control Advisory Rules Committee was charged with developing alcohol control reform proposals. Some critics, however, have cautioned that the state’s present alcohol laws are necessary to protect public health. This Policy Brief examines the health and safety effects of alcohol regulations like Michigan’s. … more
Last year, a state Liquor Control Advisory Rules Committee was charged with developing alcohol control reform proposals. Some critics, however, have cautioned that the state’s present alcohol laws are necessary to protect public health. This Policy Brief examines the health and safety effects of alcohol regulations like Michigan’s. … more
Proposals to Further Regulate Michigan’s Electricity Market: An Assessment
More than a dozen bills are pending in the Michigan Legislature to expand regulation of the electricity industry and to impose new environmental requirements on energy production and sales. As a group, these legislative proposals assume the necessity of government intervention in the production and distribution of energy. This report details the drawbacks for consumers and the economy of substituting political forces for market forces in electricity service. … more
Assessing Stricter Mercury Controls in Michigan
On April 17, 2006, Michigan Gov. Jennifer Granholm directed the Department of Environmental Quality to draft a rule under the state’s Clean Air Act to reduce mercury emissions from coal-fired power plants by 90 percent. The governor ordered the reductions to occur in two phases. The first phase is supposed to entail the reduction schedule established by the U.S. Environmental
Protection Agency last year. The second phase is supposed to exceed the federal requirements by reducing emissions 90 percent by the year 2015. … more
Groundwater Regulation: An Assessment
In proposing the Water Legacy Act, Gov. Jennifer Granholm is attempting to
increase state regulation of groundwater use through a costly and intrusive permit regime. If enacted, this drastic change would upend longstanding water rights and further weaken Michigan’s economy. … more
Assessing Electric Choice in Michigan
Ending the regional monopoly structure in the generation of electricity was intended to provide customers with lower rates and improved service quality, while also increasing generating capacity for electricity in the state. But attempts are underway to reverse the course of this restructuring. … more
Crossed Lines: Regulatory Missteps in Telecom Policy
An analysis of forced access in Michigan
Violation of property rights is the defining feature of current telecom policy. … more
Energizing Michigan's Electricity Market
Michigan is about to allow customer choice in the electric power market and, by doing so, end nearly a century of monopoly protection and guaranteed profits for electric utilities. How the state makes this free market transition will impact Michigan's competitiveness and cost of living.
The report reviews key decisions before the legislature; analyzes the Public Service Commission proposals; shows the technical, environmental, and economic impact of deregulation; compares Michigan to other states; and recommends ten specific actions to ensure fair, timely, and comprehensive customer choice. The effects of so-called stranded cost payments to utilities are assessed in detail. A four-page glossary of technical terms is included. 33 pages. … more
Timber Producer Certification in Michigan: Self-Regulation vs. State Regulation
Which form of regulation is better for solving problems, protecting consumers and the environment and encouraging rational economic planning-regulation by government or regulation by industry through free markets and incentives? Michigan State University Forestry Professor and Mackinac Center Scholar Dr. Potter-Witter argues for a self-certification model that could be applied to other industries. She also provides a thorough review of the Michigan timber market and a timely survey of literature on occupational licensing. 23 pages. … more
Road Map For a Michigan Renaissance
In the aftermath of the 1990 gubernatorial election, innovative proposals for a new incoming administration and legislature were needed. In a 20-point program, The Mackinac Center calls for a Michigan Grace Commission, welfare reform, trucking deregulation, privatization, repeal of the Prevailing Wage law, and specific tax and spending cuts. … more
Auto Insurance in Michigan: Regulation, No-Fault, and Affordability
Written by one of America's foremost authorities on auto insurance, this study is a thorough review of Michigan's Essential Insurance Act and No-Fault Law. Harrington examines in-depth the structure of rates in the state and explains that they are not the result of price-gouging or insufficient competition. He analyzes the effects of the state's insurance regulations, and makes suggestions that would increase competition, lower costs, and limit the interference of government in a free insurance market. 33 pages. … more
