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Do Economists Support FDA Pre-approval of Drugs?

May 9, 2010 in Pharmaceuticals, Public Health, Regulation | No comments

Conventional wisdom holds that economists advocate for reducing regulation on most policy arenas.  Regulation imposes costs and businesses and is often ineffective.  Further, as technology and market conditions change, regulations which were originally welfare enhancing can now become archane.

The public generally views the FDA’s pre-approval as a worthwhile endeavor.  The goal of FDA pre-approval is to protect consumers against unsafe and/or ineffective drugs.  In the world of neo-classical economics, agents have perfect information about drug quality and the role for the FDA disappears.  Even if information is not perfectly observed, the FDA’s ability to restrict the entry of potentially useful drugs into the market can be welfare destroying.  Certifying drugs as safe rather than prohibiting them through regulations may be a preferable form of spreading information.

In a recent survey of 44 leading economists, 23 support or strongly support pre-market approval of new pharmaceuticals and devices while 15 where opposed or strongly opposed (6 were neutral).  The key rationale behind the support of pre-market approval was the problem of imperfect information and also the public goods aspect of knowledge.  Fewer economists supported the notion that the government has superior ability to assure safety and  efficacy.

The majority of economists also believe:

  • the effect of pre-market approval in suppressing would-have-been benefits is often or typically overstated in public discourse.
  • doctors do not systematically error when prescribing medicines.
  • replacing the current FDA system with a simple physician prescription requirement for new drugs and devices is a bad idea
  • The current FDA system increase the amount of knowledge available on new drugs.

Economists were split as to whether drugs approved by European, Japanese, and Canadian authorities should automatically be approved for use in the U.S.

This survey shows that economists do not have a clear consensus answer to the question of whether there is “a sound market-failure rationale for the banned-till-permitted policy for drugs and devices.“

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Eligibility Requirement for California Government Health Insurance Programs

January 19, 2010 in Medicaid/Medicare, Public Health, Public Policy | No comments

The California HealthCare Foundation has an almanac entry on Children’s Health Coverage Facts and Figures.  Eligibility requirements for these programs is described in this table.  Other key findings include:

  • The proportion of children without health insurance continued to decline through 2007, though the pace of improvement has slowed.
  • Nearly 80 percent of California’s uninsured children are eligible for coverage under either Medi-Cal, Healthy families, or Healthy Kids.
  • Medi-Cal and Healthy families are key sources of coverage for children in low-income households that together have closed the coverage gap among families with incomes up to 250 percent of the federal poverty level.
  • Healthy Kids programs are also important for children’s coverage. twenty-four counties operate Healthy Kids programs and four others rely on California Kids.
  • Children are less likely to have employment-based coverage than adults and are more likely to be enrolled in public programs in California.

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H1N1: Do I have it? Do I need a vaccine?

October 20, 2009 in Contagious Disease, Public Health | No comments

Two weeks ago, the U.S. government released its H1N1 vaccine to the public.  Many people have had a number of questions about whether or not they should get the vaccine.  The CDC website has a list of Key Facts and a Q&A section that is helpful.  

There are five major groups who should have priority of getting the vaccine:

  • pregnant women,
  • people who live with or provide care for infants younger than 6 months (e.g., parents, siblings, and day care providers),
  • health care and emergency medical services personnel,
  • people 6 months through 24 years of age, and,
  • people 25 years through 64 years of age who have certain medical conditions that put them at higher risk for influenza-related complications.

There are a number of people who should NOT get the vaccine.

  • People who have a severe allergy to chicken eggs.
  • People who have had a severe reaction to an influenza vaccination.
  • People who developed Guillain-Barré syndrome (GBS) within 6 weeks of getting an influenza vaccine previously.
  • Children younger than 6 months of age (influenza vaccine is not approved for this age group), and
  • People who have a moderate-to-severe illness with a fever (they should wait until they recover to get vaccinated.)

The H1N1 vaccine is prepared using the same method as used for the seasonal flu.  However, because the H1N1 vaccine was developed too late, it could not be added to the seasonal flu vaccine.  Thus there are two flu shots available now, one for the seasonal flu and one for H1N1. 

If you think you have the H1N1 illness, you can use this self assessment tool to verify whether or not you should see a doctor.

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Ten questions to ask your doctor

October 1, 2009 in Public Health | 1 comment

After viewing a cute ad, I went to the AHRQ homepage.  The agency gives a nice list of 10 recommended questions you should ask your doctor. Additional questions directly pertaining to specific types of care are also available.

  1. What is the test for?
  2. How many times have you done this?
  3. When will I get the results?
  4. Why do I need this surgery?
  5. Are there any alternatives to surgery?
  6. What are the possible complications?
  7. Which hospital is best for my needs?
  8. How do you spell the name of that drug?
  9. Are there any side effects?
  10. Will this medicine interact with medicines that I’m already taking?

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Vice

May 22, 2009 in Public Health | No comments

Economic Inquiry has some interesting articles on the vices of drinking and smoking:

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