The debate over the federal health care law has obscured a health problem that the president himself acknowledges -- a "severe and frequent" shortage of critical medicines. Lawmakers need a correct diagnosis if they are to provide the right remedy for this problem, which is getting worse.

According to the Food and Drug Administration, last year more than 250 drugs experienced shortages, up from 61 in 2005 and 178 in 2010.

Such shortages are primarily of injectable drugs for cancer and other therapies. That is a concern not only for patients but hospital and health-system pharmacists, as well as oncologists, anesthesiologists and other specialists.

President Barack Obama has mandated that drug companies give the FDA six months advance notice of any drug shortage or if they plan to discontinue a drug. Although well intentioned, this bureaucratic approach ignores a key reality: The very drug shortages the president laments took place on the FDA's watch.

It's the FDA's own burdensome regulations that keep the drugmakers from responding quickly to drug shortages. Instead of setting standards and monitoring outcomes, the FDA gets heavily involved in the details of drug manufacturing. That makes for slow approval of both new generic medicines and proposed manufacturing facilities, and that contributes to shortages.

So it doesn't follow that making FDA regulations more onerous, or giving the agency more power and money, will alleviate the current shortage. Europeans are not experiencing a similar drug shortage, nor does there appear to be any raw material shortage, so the difficulty must lie somewhere in the American regulatory system itself.

Some believe the cause is on the demand side, in government-dictated rebates or discounts for programs such as Medicare, Medicaid and the program for safety-net hospitals and clinics. The evidence, however, points more to the supply side.

Americans have good reason to be skeptical about President Obama's new law to increase the FDA's power by compelling six-month shortage warnings from drug manufacturers and adopting user fees for the generic drug industry. The past 20 years confirm that just giving the agency more money does not guarantee Americans better access to medicines.

Instead, Americans should be allowed to make informed use of medicines approved by non-FDA sources in other developed countries. While they are at it, lawmakers should end the FDA's monopoly over drug certification and make the agency a "certifier of certifiers."

Independent certifiers would have better incentives to deliver cost-effective quality assurance. Such entities already exist, the most familiar being Underwriters Laboratories, which certifies tens of thousands of products for fire safety.

Severe and frequent shortages that have occurred on the watch of an unreformed government bureaucracy will not be cured by giving that same bureaucracy more power or money. Lawmakers should instead reduce the FDA's power and liberate patients to use drugs from additional sources.

Above all, the system should encourage entrepreneurs to enter the market faster, with innovative production techniques. Together, these long-overdue reforms will increase the supply of crucial medicines, lower prices and better serve the well-being of all Americans.

Source: http://www.freep.com/article/20120712/OPINION05/207120424/Mackinac-Center-Bigger-and-costlier-bureaucracy-won-t-cure-medicine-shortages?odyssey=mod|newswell|text|FRONTPAGE|s