EDITORIAL: Compounding Obamacare

FDA pushes for expanded authority to regulate pharmacies that mix medicines

Forcing Americans to give up their favorite doctors and health plans through Obamacare isn’t all the administration plans to do to shake up health care. It’s going after the corner drugstore pharmacist with a scheme to require Mom-and-Pop druggists to take further orders from the bureaucrats at the Food and Drug Administration.

Most Americans think their pharmacists are doing fine now, without the federal government’s help. Pharmacists, Gallup tells us, are second only to nurses on the list of America’s most trusted professionals; 75 percent of those surveyed say pharmacists live up to high ethical standards. The federal government is scheming to take oversight of compounding pharmacies out of the hands of state authorities and put it in the hands of those who can only dream of positive ratings like those of pharmacists. Congressmen, at 10 percent, are found at the bottom of the trust list with used car salesmen (and Washington journalists).

“Compounding” is the process by which druggists mix together a combination of ingredients to fill a particular prescription, as directed by a physician. Compounding can be an economical alternative to off-the-shelf pills mixed and packaged by pharmaceutical manufacturers. A pharmacist can add a touch of flavor to a child’s medicine to make it go down a little easier, for example. Compounding can save lives when the drugstore shelves are bare because the major drug manufacturers can’t keep up with demand for a popular treatment, as happened during the 2009 flu pandemic. All pharmacists once compounded prescriptions from bottles they kept on their shelves, but owing to the rising cost of compounding, the frequent shortage of drugs and consumer convenience, compounding has fallen out of widespread fashion. Economies of scale, not a lack of quality or inefficiency, led to using the manufacturers’ ready-made pills and potions.

Supporters of expanded federal authority cite a deadly meningitis outbreak last October traced to the New England Compounding Center. Nearly 70 people died when proper sterilization procedures were not followed in the preparation of 17,676 doses of a compounded medication that was shipped in bulk to 23 states. The Senate Health, Education, Labor and Pensions Committee in May unanimously adopted legislation putting the federal government in charge of regulating the industry.

It’s never quite that simple. Community pharmacists already fall under the scrutiny of state regulators. A House Energy and Commerce Committee investigation found that the FDA conceded in a 2006 letter that it had authority under U.S. law to regulate the New England Compounding Center as a “manufacturer,” because it shipped medicines in bulk, rather than in response to a particular patient’s individual prescription. Despite this existing authority, the FDA ignored numerous warnings about potential unsanitary conditions at New England Compounding Center. “We found that FDA focused on perfecting their legal reasons for inaction instead of protecting families,” said Rep. Fred Upton of Michigan, the committee chairman, and Rep. Tim Murphy of Pennsylvania. “Even the FDA staff wanted to go back and inspect these unsanitary manufacturers, but FDA supervisors said ‘no.’”

Regulation doesn’t guarantee increased safety, but it does come at a cost. Mom-and-Pop pharmacies are concerned that their small businesses will be swept into the same federal regulatory category as the large-scale operations. The National Community Pharmacists Association, which represents 23,000 independent drugstores, sent a letter to House lawmakers last week endorsing the more balanced legislative proposal put forward by Rep. Morgan Griffith, who would clarify the roles of state regulators and the FDA without getting between the needs of patients and the response of their doctors and their pharmacists.

The biggest fault (among many) with Obamacare is that it treats every patient as a number, herding individuals into one-size-fits-all government-sanctioned treatments. The personalized service of a community pharmacist has no place in Obamacare, which is all the more reason to preserve what’s left of their independence from Washington’s overreaching bureaucrats.

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