Who Forgot to Fix Compounding Law?
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 this state.
But 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.”
One minute later the House staff attorney, Michael Poche, sent it to others on the committee staff and it quickly moved up the chain of command. Poche wrote “Rough draft notes from the BOP (Board of Pharmacy)… More information is forthcoming.”
That was the end of the trail, and the beginning of the mystery. Health News Florida asked DOH for any evidence that the agency followed up. None was provided.
Members of the Board of Pharmacy failed to return e-mails and phone calls. One member, who was reached by phone at her desk, said the DOH press office had warned them not to talk to reporters.
Members of professional boards are not state employees and are presumably free to talk to whoever they want. However, they are appointed by the governor.
So in order to report this article, Health News Florida attended or listened to recordings of all the meetings of the pharmacy board and its compounding committee that took place since the threat became clear last fall.
Will a Year’s Delay Matter?
The death toll from last year’s outbreak of fungal meningitis continues to rise. The Centers for Disease Control and Prevention added three deaths this week, bringing the total to 58, including five from Florida.
The pharmacy that made the tainted drugs, New England Compounding Center, was shut down soon after the outbreak was discovered in September. It is now bankrupt, but other compounders have stepped in to fill the orders.
Last week, Main Street Family Pharmacy of Newbern, Tenn., was identified as the source of an outbreak of skin abscesses caused by contaminated steroids – the very same drug that the Massachusetts center had produced, methylprednisolone acetate, or MPA.
The CDC says 24 cases linked to the Newbern pharmacy have been reported in four states; Florida has the highest number of cases, 13. So far, this infection has not been fatal.
On Thursday, the Food and Drug Administration reported that its scientists had verified microbial contamination – both bacteria and fungi – in vials from two batches of drugs from the pharmacy.