Letter to Editor Regarding Compounding

As submitted to the Minnesota Star-Tribune

To the Editor:

To hopefully help prevent another tragedy like the meningitis outbreak, we have spent countless hours working constructively with Sen. Al Franken (D-Minn.) and other legislative leaders. Your editorial ("Bring drug compounding firms out of the shadows," Aug. 2) was misleading. The fact remains that this well-intentioned legislation (S. 959) needs further refining.

First, the suggestion that S. 959 leaves independent community pharmacies "essentially untouched" is incorrect. The bill significantly increases Food and Drug Administration (FDA) authority over traditional pharmacies. It gives FDA blanket authority over which customized (or "compounded") medications community pharmacists can prepare for patients at the request of their doctor. In addition, the bill infringes upon community pharmacists' ability to compound medications to alleviate increasingly common shortages of manufactured drugs.

Second, the meningitis tragedy was caused by the reckless actions of one company, but it was facilitated by the failure of the state board of pharmacy (which regulates pharmacies) and FDA to coordinate, communicate and take action. S.959 erects additional siloes between FDA and state boards of pharmacy when better interaction between the two is necessary.

Third, while new legislation may be warranted, your editorial failed to acknowledge that, this year alone, FDA has inspected over 30 large-scale compounding companies and facilitated many drug recalls. No law has yet changed; only the FDA's approach.

We believe the Senate can and must do better before moving this legislation forward.

Sincerely,
B. Douglas Hoey, RPh, MBA
CEO
National Community Pharmacists Association
Alexandria, VA

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