Is CDUFA Next? Hamburg Wants Congress To Think About A Compounder User Fee

FDA commissioner says in a blog post that the additional authority FDA requires to oversee compounders also would require more money, which could come through registration or other fees.

FDA Commissioner Margaret Hamburg wants Congress to explore a compounding pharmacy user fee to pay for increased agency oversight of the industry.

In a March 22 blog post reiterating that the agency needs more authority to properly regulate compounding, Hamburg said additional funding would be necessary to handle the new duties.

Among the possibilities could be compounder fee payments, she said.

“We look forward to working with Congress to explore funding mechanisms, which could include registration or other fees, as Congress has authorized and FDA has successfully implemented in other settings,” Hamburg said.

Hamburg has asked that states continue monitoring the traditional compounding practice, which involves preparing a medication for individual patients.

She wants FDA to regulate “non-traditional” compounders, which are sterile operations that make products at high volume and involve more risk.

High-risk compounders would be required to register with the agency, comply with federal quality standards, and report serious adverse events, according to the blog post.

Hamburg wants FDA to have the authority to look at all compounders’ records and prohibit “compounding of the most complex and highest-risk products,” that is products that should only be made by manufacturers according to an approved NDA. She also wants to consider potentially requiring compounded products to have their nature and source identified in their labels, according the post.

The recognition that additional funding would be required to upgrade FDA’s compounder oversight is not surprising and neither is the fact that a significant portion or all of it could come from industry fee payments.

FDA funding from the treasury is shrinking as Congress looks to cut spending across the federal government. The agency lost $209 million when the budget sequester went into effect (Also see "Sequestration Day: FDA Will Manage For Now, But Could Suffer Later If Hiring Deferred" - Pink Sheet, 1 Mar, 2013.).

However, the continuing resolution the House and Senate passed to fund the government through the end of September did include about a $9 million increase over the fiscal year 2012 budget level, according to the Alliance for a Stronger FDA.

Members of the Senate Health, Education, Labor and Pensions Committee said during a November 2012 hearing looking into the deadly meningitis outbreak linked to the New England Compounding Center that FDA may need more resources if it is to take on more responsibility.

Hamburg said at the hearing it may be best to have FDA regulate all high-risk sterile compounders, those she called “non-traditional,” but it was unclear how many there were. She said a large number could stretch resources.

Sen. Lamar Alexander, R-Tenn., said at the time it was more important for either FDA or a state to have the ultimate responsibility for the industry (Also see "Compounding The Problem: Congress, FDA Argue Over Regulatory Responsibility" - Pink Sheet, 19 Nov, 2012.).

Fees May Require Months Of Negotiations

Imposing a user fee may end up as the easiest way to ensure FDA can handle the mandate, if in fact it receives that authority.

Prescription and generic drug, medical device and biosimilar sponsors now pay fees that support FDA inspections and application reviews. The generic and biosimilar fee programs launched Oct. 1, 2012.

If prior user fee experience is followed, however, it could be several months or longer before the fee actually is collected. PDUFA, GDUFA, BsUFA and MDUFMA also required months of negotiations with industry representatives to determine program goals and frameworks (Also see "Buying Time: Industry Sacrifices Early To Gain Later With PDUFA V Review Model" - Pink Sheet, 1 Oct, 2012.).

The HELP Committee is working on compounding legislation, which could be ready in the coming months.

House members were unconvinced FDA needs more authority. The House Energy and Commerce Committee asked FDA for additional records to help determine what, if anything, should be done. The committee has said it will not consider legislation until it receives all the desired information (Also see "Compounders’ Policy Shift Creates Opportunity For Broad Legislative Proposal" - Pink Sheet, 22 Feb, 2013.).

Inspectors Still Impeded At Pharmacies

Hamburg’s continued push for compounding legislation comes as FDA is ramping up inspections of compounding pharmacies.

The agency also announced two recalls of compounded medications on March 20 that were due to quality problems.

MedPrep Consulting Inc. recalled all of its products due to potential mold contamination after a Connecticut hospital found mold in bags of intravenous solution made at the facility, the agency said in a statement.

Clinical Specialties also recalled all lots of its repackaged sterile products after five patients taking Avastin (bevacizumab) from the facility suffered severe eye infections. The recall came due to concerns that the compounder could not assure its products’ sterility, FDA said in a press release.

Some FDA reports from earlier inspections found similar problems at a number of pharmacies, including not assuring equipment and workspaces were properly sterilized (Also see "FDA Compounder Inspections May Help Set New Enforcement Standard" - Pink Sheet, 11 Mar, 2013.).

FDA has inspected more than 30 compounding facilities in the past two months, according to the blog post. But Hamburg also said that FDA staff continue to face road blocks in accessing records.

“Even during this time of heightened awareness, our inspectors are being delayed in their work or denied full access to records at some of the facilities we are inspecting,” she said in the blog post.

The Energy and Commerce Committee asked the International Academy of Compounding Pharmacists in December 2012 for internal communications because it may have coached members to impede federal and state regulator requests for quality checks (Also see "Congress Expands Compounding Investigation To Trade Group" - Pink Sheet, 7 Dec, 2012.).