GPhA, BIO Join In Outlining Problems With House Compounding Bill

The groups typically do not fall on the same side in policy fights, but say in a letter that compounding restrictions proposed in Rep. Griffith’s Compounding Clarity Act are “not that limiting.”

In a somewhat unusual move, brand and generic industry trade groups not only agree in their critique of pending legislation, but also are pushing for stricter regulation.

Rep. Morgan Griffith’s compounding bill is the target of the unusual correspondence.

The Biotechnology Industry Organization and Generic Pharmaceutical Association, many times opponents in policy debates, co-signed a letter to Griffith, R-Va., and co-sponsors Gene Green, D-Texas, and Diana DeGette, D-Colo., asking for a tougher barrier to entry for compounded medications.

Copies also were cc’d to House Energy and Commerce Committee Chairman Fred Upton, R-Mich., and Ranking Member Henry Waxman, D-Calif., and Senate Health, Education, Labor and Pensions Committee Chairman Tom Harkin, D-Iowa, and Ranking Member Lamar Alexander, R-Tenn.

The letter, dated Sept. 13, comes as negotiations between House and Senate officials continue crafting a legislative package.

Among the trade groups’ primary concerns was that it could allow “entities not regulated as manufacturers … to engage in large-scale compounding/repackaging of sterile products in advance of valid prescriptions for identified individual patients.”

Griffith introduced the Compounding Clarity Act, H.R. 3089, on Sept. 12, which seeks to allow FDA the ability to oversee large-scale compounding pharmacies like the New England Compounding Center, which produced contaminated steroid injections that lead to a deadly meningitis outbreak.

The bill states that large-scale compounders, termed outsourcing facilities, would be subject to inspections, user fees and other regulations if the total number of compounded products dispensed for office use and shipped between states exceeds 5% of their total products dispensed during a six-month period (Also see "House Compounding Bill Would Regulate “Outsourcing Facilities” With Volume Limits" - Pink Sheet, 13 Sep, 2013.).

GPhA and BIO said in the letter that while the bill attempts to curtail which facilities could conduct that type of compounding, the “limitations are not that limiting at all.”

“The 5% cap … should include intrastate and non-sterile product compounding, and there should be a relatively short ‘beyond-use’ date,” they said in the letter.

The groups also were “deeply troubled” by the absence of language prohibiting compounding and distribution of marketed drugs included on FDA’s drug shortage list once the shortage is over.

The Compounding Clarity Act prohibits the compounding of “essentially a copy of a marketed and approved drug product,” but states that a drug on the shortage list is exempt.

GPhA and BIO also argued the definition of “essentially a copy of a marketed drug” and “currently marketed” in the legislation “are ambiguous and could permit the large-scale compounding of unauthorized copies of approved drugs” and may devalue innovation incentives like Hatch-Waxman exclusivity, according to the letter.

Generic, Brand Groups Share Incentive On Compounding

Both groups have incentives to limit compounding as much as possible. BIO might be trying to limit the repackaging of one its leading member’s leading products – Genentech Inc.’s Avastin (bevacizumab).

And GPhA members loss sales to compounders more directly; generic firms were selling many of the products that the New England Compounding Center was, albeit with a GMP mark-up.

Since innovator and generic manufacturers must adhere to current Good Manufacturing Practices and submit to regular FDA inspections, the groups do not want compounders undercutting that process.

FDA has said that if it gains oversight authority over large-scale compounders, it likely would write specific GMPs for them to follow (Also see "Sterile Compounders Would Get Tailored Manufacturing Regs If FDA Gets New Authority" - Pink Sheet, 9 May, 2013.).

Despite their frequent clashes, including the ongoing battles over state biosimilar legislation, GPhA and BIO have found common ground before, supporting Senate legislation that would exempt FDA user fees from sequestration.

Like with the compounding bill, both groups have similar interests in ensuring fees paid by member companies are used as intended (Also see "News Briefs: Senate Introduces User Fee Bill; Lawsuit Ends Over Conflict Minerals" - Medtech Insight, 5 Aug, 2013.).

House, Senate Negotiations Continue

With the crisis in Syria no longer all absorbing on Capitol Hill, there may be more time for Congress to deal with compounding, although the bill still may compete with budget and debt ceiling issues for floor time.

Negotiations between the chambers are ongoing and have continued since recent bill introductions, said Gabrielle Cosel, a drug safety expert at The Pew Charitable Trusts.

Cosel also said Pew is encouraged by Congress’ continued prioritization of the issue and should not miss the opportunity to strengthen the oversight system.

The Senate HELP Committee already has passed a compounding bill, which it combined with drug tracking standards, sent to the floor for consideration (Also see "Compounding Bill Glides Toward Senate Floor; FDA Gets More Flexibility On Fees" - Pink Sheet, 22 May, 2013.).

Griffith’s bill may present an opening in the House, given that it has bipartisan support. Democrats and Republicans had sparred over whether FDA even needed more authority to adequately regulate compounding (Also see "FDA Compounding Enforcement Could Have Been More Aggressive, Hamburg Acknowledges; Tense Hearing Continues Legislative Stalemate" - Pink Sheet, 16 Apr, 2013.).

While the Senate version includes some significant differences from Griffith’s bill, the Compounding Clarity Act did incorporate similar user fee language. It also uses the same volume metric as the Senate bill, but a smaller percentage (5% to the Senate’s 10%).

A compromise on drug tracking legislation also may be necessary to move the compounding bill. The House already has approved a track-and-trace bill, but it is different from the pending Senate bill (Also see "Track-and-Trace Bill Clears House With New Electronic Labeling Language" - Pink Sheet, 3 Jun, 2013.).