The FDA IS Being Very Smart In its Actions to Show Congress That Legislation Is Needed

September 11, 2013

by Sue Tuck Richmond

The article, Compounding Pharmacy Drug Recalls Issued Due to Lab Testing Problems, shows just how smart the FDA is being these days.  After it was criticized for not doing more in cases such as the NECC meningitus outbreak, the FDA choose to take action.  The FDA choose to show Congress

just how compounding pharmacies and testing laboratories acted when they attempted to exercise any authority over them.  This was a win-win situation for the FDA.  If compounding pharmacies and testing laboratories didn't challenge the FDA's authority then the FDA would be able to clean up compounding pharmacies and provide more protection to the public from any harmful compounded medications while at the same time having these same pharmacies basically consent and agreeing to the FDA's authority.  If, on the other hand, these compounding pharmacies and testing labs challenged the FDA's authority, this just proved the FDA's point:  it needs Congress to pass legislation clarifying or even strengthen the FDA’s power.  In Compounding Pharmacy Drug Recalls Issued Due to Lab Testing Problems,  Irvin Jackson, points out just what is happening:

By going after Front Range, a testing laboratory, the FDA has been able to indirectly leverage some compounding pharmacies to recall drugs that might be harmful to the public. However, the company responded to the FDA’s inspection and concerns by doing what many compounding pharmacies have done: challenge the FDA’s authority to ensure that all drugs given to the public are safe

Now it is up to Congress to provide the answer:  it must pass legislation clarifying or even strengthen the FDA's power in this area.