Is The FDA Stepping Too Far?

The well publicized fungal meningitis outbreak about two years ago which was traced back to a compounding pharmacy killed 64 individuals. The FDA has since tightened the screws on these businesses. Countless FDA inspections have been made since then resulting in deficiency citations, fines and even a warning written by the FDA for consumers to avoid certain facilities.

According to the WSJ “the stepped-up oversight was hastened by a new law that bolstered FDA authority. But compounders say the get-tough approach is a double-edged sword. Hospitals, doctors and patients may eventually have more confidence in compounded’ medicines, but in the meantime costs and red tape have increased. And a new batch of proposed guidelines issued by the FDA last week has set off another round of anguish.”

Pharmacists are protesting claiming that for the sloppiness of one facility all the good, rule-following pharmacies are going to be affected by such onerous restrictions. Ultimately the consumer suffers by such regulatory strangulation with fewer facilities, less choice and perhaps higher prices.

Two particular stipulations are causing the havoc. The first has to do with the interstate shipping of compounds. The FDA wants to restrict to a small percentage, the shipping out of state. The hardship of course is that may compounding pharmacies receive orders outside of their home state and thus such restrictions would hit the bottom line very hard. The second has to do with expiration dates and the amount of time that a compounded mixture had to be injected or administered.

The International Academy of Compounding Pharmacies spokesman said “there are some compounding pharmacies that are highly specialized in what they do, and they get patient referrals from all over the U.S. Why should they be limited at all if they are filling one prescription at a time in accordance with the regulations?”

Compounders that follow sterility and safety standards will be affected severely by further regulation in and already highly regulated and scrutinized industry.