Friday, June 7, 2013

MUST READ!! Who Forgot to Fix Compounding Law?


7:39 am
Fri June 7, 2013

The 2013 Legislature could have fixed a tiny gap in Florida law that blocks health officials from regulating hundreds of out-of-state compounding pharmacies that ship high-risk drugs into thiBut that didn’t happen. No bill was ever filed.

The Florida Department of Health’s press officers say the agency provided the necessary information to the House health committee staff. But a key House member familiar with the matter says DOH provided only a draft and was supposed to give the final go-ahead.

“We kept waiting and waiting,” said Rep. Ken Roberson, chairman of the Health Quality Subcommittee.   “We did not receive any definitive word. I kept asking, ‘Have we heard anything from DOH on this issue?‘”

The answer was always no, he says. And he doesn’t know why.

The gap in the law

After a lethal outbreak triggered by contaminants from New England Compounding Center was discovered in September of last year, DOH and the Board of Pharmacy swung into action.

Records show a special compounding committee did months of research, held workshops, and eventually won board approval to require that “sterile” compounding pharmacies – the ones that deal in high-risk drugs – get a special permit.  That way, DOH would know which pharmacies needed close attention and could send its most experienced inspectors.

The Board could take such a step for in-state compounders through the rule-making process, the committee discovered. But those in other states would require an addition to Chapter 465 of Florida Statutes. So would the right to inspect them.

Current law says DOH can inspect any pharmacy or other place where drugs are made, stored or sold – as long as it is in the state. Those three words needed to be struck from the law, the committee said.

The committee had a pretty good idea of what needed to be done as early as January and the board was clued in by February, recordings of meetings show. At a workshop March 22, the full Board of Pharmacy hammered out the draft changes to the law and rules, and on April 2, members formally voted to endorse them, minutes show.

Roberson said he could have pushed the measure through before the end of the legislative session on May 3 – if DOH and the legislative staff moved quickly and communicated well.

That, apparently, didn’t happen.

The e-mail trail

Under Surgeon General John Armstrong, DOH employees say they are not allowed to speak to reporters – a distinct change from the policies of Armstrong’s predecessor, Dr. Frank Farmer. In this case, Health News Florida spent a month trying to talk to officials who might know what happened. But the only DOH staff members who would speak on the record were those in the press office.

In e-mails, they said that DOH’s legislative staff met with House health committee staff in early March and sent the needed statutory changes on March 22. So Health News Florida obtained the records.

The proposed changes were in an attachment to an e-mail that was written by Assistant Attorney General David Flynn, who serves as general counsel to the Board of Pharmacy. He sent them to the pharmacy board’s Executive Director Mark Whitten, with only a short phrase: “Notes incomplete.” He also put “Notes” in the subject line.

Whitten forwarded it about 15 minutes later to the DOH legislative affairs staff, saying he would call them in a few minutes. An hour later, records show, Legislative Affairs Director Michael Cantens sent the e-mail to an attorney for the House committee. Cantens typed:  “from today’s pharmacy meeting.”
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