Published: 27 September 2013 01:26 PM
Updated: 27 September 2013 01:31 PMA compromise bill that would increase federal regulation of pharmaceutical compounders has been agreed to by sponsors in the House and Senate, and could face a key vote as soon as tomorrow in the House energy and commerce committee.
Its fate, hanging in the balance over the next few days, underscores how difficult it can be to craft new regulations for businesses well-armed to fend off what they see as needless federal intrusion and costly red tape, even if safety advocates say the changes are needed to keep patients safe from deadly mistakes.
Earlier this week we looked at mounting pressure to bring compounders under tighter federal scrutiny in the wake of last year's disastrous meningitis outbreak that left dozens dead after contaminated steroids were injected in patients across the country.
Two versions had been put forth - a tougher bill that had passed a senate committee and a draft bill in the House that had drawn lighter opposition from the industry.
The compromise essentially would create a class of compounders called "outsourcing facilities" that would be regulated and inspected by the U.S. Food and Drug Administration. But the compounders would have the choice of designating themselves as outsourcing facilities, making the tougher scrutiny voluntary. In return, they'd be offered a kind of FDA seal of approval that competitors who don't submit to the scrutiny wouldn't have.
A committee report on the key provisions of the bill reads:
SEC. 102. OUTSOURCING FACILITIES. This section would add a new section 503B to the Food, Drug, and Cosmetic Act (FFDCA) allowing a facility that is engaged in the compounding of sterile drug products to register with the FDA as an outsourcing facility. Such facilities would be inspected by the FDA on a risk-based schedule and required to follow current good manufacturing practices (cGMPs) in addition to having to meet other standards and requirements. SEC. 103. PENALTIES. This section would add several prohibited acts associated with compounded drugs, including the intentional falsification of prescriptions for such products. SEC. 104. REGULATIONS. This section would require the Secretary to follow the formal rulemaking process when promulgating regulations to implement this title. SEC. 105. ENHANCED COMMUNICATION. This section would require the Secretary to facilitate meaningful communication between the agency and the State boards of pharmacy about concerns raised, or actions taken, against compounding pharmacies.
But The Houston-based International Academy of Compounding Pharmacists opposed the initial Senate bill and continues to have "many concerns" about the compromise, according to a post to members on its website.
I've got calls into several Texans who serve on the Energy and Commerce Committee, and will update this post when I hear back about who is supporting what.In a sign that the compromise has the support of the GOP leadership, the committee posted a link to more than a dozen letters sent by supporters of the compromise bill.