Showing posts with label MedPage Today. Show all posts
Showing posts with label MedPage Today. Show all posts

Wednesday, July 17, 2013

House Inches Toward Oversight of Compounding Published: Jul 17, 2013 By David Pittman, Washington Correspondent, MedPage Today

WASHINGTON -- Congress is wrangling with the issue of where to draw the line between state and federal oversight of large-scale compounding pharmacies in light of a series of infections -- including a deadly fungal meningitis outbreak -- linked to the facilities.
There now appears to be general agreement the FDA needs more clear authority over compounding manufacturers -- pharmacies that compound bulk supplies of drugs in advance of a patient prescription.
But a hearing Tuesday before the House Energy and Commerce Health Subcommittee shed greater light on the intricacies associated with such regulation.
Lawmakers signaled an unwillingness to tighten regulation of the pharmacies citing the service that the compounders provide to physicians treating patients who don't respond to or cannot tolerate medications mass produced by brand and generic pharmacuetical companies. At the same time, Congress doesn't want to be seen as enabling shoddy oversight of large-scale compounders like the New England Compounding Center (NECC).
Last fall, the Framingham, Mass., compounder was the subject of a multistate fungal meningitis outbreak that killed more than 60 people and sickened another 740. Other outbreaks linked to compounding pharmacies have occurred since then -- including in Tennessee and New Jersey -- although neither was as severe.
Congress has worked for nearly 9 months to address gaps in oversight of compounders after the FDA said NECC exploited gaps in regulation between state boards of pharmacies and the FDA.
Rep. Morgan Griffith, a freshman Republican from Virginia, is drafting legislation that would place certain compounding pharmacies under the FDA's purview. They would supersede state oversight if they pass certain criteria such as volume thresholds, but the bill is still in draft form and lawmakers are tinkering with it.
"I don't think our bill would have allowed the NECC situation to occur," Griffith told MedPage Today after the hearing.
Additionally, subjecting compounding pharmacies who ship drugs across state lines to FDA oversight would limit the business of those pharmacies, Griffith said.
For example, in his district in southwest Virginia, a person can drive between Tennessee, North Carolina, Virginia, and West Virginia within 90 minutes.
A Senate bill which the Health, Education, Labor and Pensions Committee approved in Maywould place under the FDA's authority compounders that produce sterile drugs without a prescription and ship those drugs across state lines. That bill, S. 959, could come before the full Senate for a vote by the end of this month.
Some organizations, including the trade group Pharmaceutical Research and Manufacturers of America (PhRMA), argue that such an addition would create confusion between traditional pharmacies and large-scale compounders and between compounders and traditional manufacturers.
Public Citizen's Health Research Group, a consumer organization often at odds with PhRMA, criticized both Griffith's draft bill and the Senate bill along lines similar to PhRMA's, saying the Senate bill would create a "second, substandard tier of drug manufacturers, confusingly called 'compounding manufacturers,'" which would not be required to get new drug approval by the FDA or comply with the standard federal labeling requirements.
In addition, neither of the bills "would require compounding pharmacies that mass-produce standardized drugs to seek pre-market approval from the FDA or meet important federal labeling requirements," the group said in written comments to the subcommittee.
Some lawmakers, including Del. Donna Christensen, MD (D-V.I.), have voiced concern that not allowing some limited number of "office stock" or advance prescriptions from compounders -- even with no FDA oversight -- could hinder more immediate access to certain drugs. Such prescriptions would be subject to FDA oversight under the Senate bill if they crossed state lines.
Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said volume alone is a difficult proxy to judge risk. A compounder could ship several small batches to hundreds of providers and suddenly be a large-scale manufacturer like the NECC.
"It's a difficult line to draw," Woodcock said.
Griffith's bill also provides an exemption for advanced compounding as long as a patient-specific prescription is reported back 7 days after a prescription is administered. Woodcock later said the 7-day provision could be a loophole pharmacies could exploit.
House Republicans have been hesitant to create a new class of compounding manufacturers -- separate from traditional manufacturers and traditional compounders -- saying the FDA had all the power it needed under current law to stop the NECC outbreak.
"I'm willing to update the authority the FDA already has," Rep. Mike Burgess, MD (R-Texas), said Tuesday. "I don't know if I'm willing to invest the FDA with new authority."
quoted from here