Proposal gives FDA too much oversight

Monday, April 30, 2007

WASHINGTON - Proposed legislation would increase Food and Drug Administration (FDA) oversight of compounded preparations--something many call unnecessary and overreaching.
Sponsored by Edward Kennedy, D-Mass., Pat Roberts, R-Kan and Richard Burr, R-N.C., the Safe Drug Compounding Act of 2007 would restrict the practice of compounding to products prepared in limited amounts for individual patients with a valid prescription for which there is no commercially available equivalent.
"They are putting a lot of restrictions on the amount of compounding a pharmacy is doing," said Lisa Smith, an attorney with Amarillo, Texas-based Brown & Fortunato. "It looks like they are still going to use that as a criteria for when a pharmacy crosses the line to manufacturing."
The legislation would also require compounded preparations to be labeled as "not prepared using FDA's manufacturing standards for sterile drugs."
The industry maintains that it adheres to rigid state and federal pharmacy guidelines.
"The risk of contamination isn't greater at a pharmacy," said Joe Lewarski, vice president of clinical and government affairs for Inogen. "If you violate the rules, it doesn't matter if (it's a pharmacy or manufacturer)."
In a March 7 letter, a coalition of nine pharmacy organizations expressed concerns that the legislation would:
* Insert the FDA into the physician-patient relationship by giving a federal agency authority to determine when compounded medications are needed;
* Create new documentation requirements for physicians;
* Duplicate already established guidelines for sterile compounding; and
* Remove authority of state boards of pharmacy.