The House and Senate Appropriations Committees with oversight of FDA have been very busy.
Both voted out draft bills for FY 2015 that include appropriations for FDA and released draft reports. Roger Szemraj and the rest of our government relations practice have scoured the draft bills and reports looking for insight into what FDA drug-related activities are vexing Congress.
The Basics
On May 29, by a vote of 31-18, the full House Appropriations Committee voted out a draft version of the FY 2015 Appropriations Bill for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies (the House Bill) and an accompanying draft House Report. On May 22, by a vote of 30-0, the full Senate Appropriations Committee approved S. 2389, the FY 2015 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill (the Senate Bill) and issued its Senate Report.
The President’s budget sought $2,575,383,000 for FDA. In the House Bill, FDA receives an appropriation of $2,574,080,000; an increase of $22,175,000 over the amount provided in FY 2014, though still $1,303,000 below the budget request. The Senate was slightly more generous, appropriating $2,588,536,000; an increase of $36,631,000 over the amount provided in FY 2014, and $13,153,000 above the budget request.
Although the Bills and Reports address myriad issues, including agricultural and conservation programs, rural development, and domestic food and nutrition programs (and we refer you back to our public policy professionals if you are interested in those issues), we’re focused here on what the House and Senate Bills and Reports have to say about FDA’s regulatory agenda for drugs.
House Bill and Report
Generic Drug Labeling Proposed Rule Targeted
The Committee was “deeply concerned” about the generic drug labeling proposed rule. As the Committee presented the issue, the proposed rule would “change longstanding policy and allow generics to alter their label without FDA’s prior approval.” The proposed rule has proven to be controversial with many comments filed in objection. See, e.g., Comments by Generic Pharmaceutical Association (GPhA) and National Conference of State Legislatures; compare Comment by Public Citizen.
The House Appropriations Committee bluntly stated in its report that it “is unaware of evidence of a need to change existing regulations.” Going further, the Committee stated that the generic drug labeling proposed rule “has the potential to threaten public health by creating unprecedented patient and provider confusion by having multiple labels for the same product, therefore undermining the longstanding policy of sameness.”
The Committee also challenged the FDA’s cost estimates for implementation of the proposed rule. Contrary to FDA’s assertions of modest cost to implement the rule, others estimated the rule’s implementation costs to be in the billions. The Committee believes that “sufficient evidence is lacking on how FDA derived such a low cost estimate for this proposed rule.” The House Committee “directs the agency to complete a new economic analysis of the rule, paying particular attention to the cost of pharmaceutical products, before FDA finalizes the rule and report back to the Committee on Appropriations of both Houses of Congress within 90 days of enactment of this Act.”
Other Items of Interest in the House Report
The House Appropriations Committee was also concerned about the following additional FDA drug matters:
- ANDA Review Prioritization – Within 45 days of enactment, the Committee directs FDA to report how it has prioritized its ANDA review process to expedite the review of Paragraph IV applications and ensure first generics are approved on the earliest possible date.
- FDA User Fee Collections/Obligations – The Committee continues to be concerned about the financial management of FDA’s User Fee programs. The Committee directs the submission of period reports on user fees collected for each user fee program included in the Act.
- Imports – The Secretary, in consultation with Homeland Security and Customs and Border Protection, should consider reprioritizing existing funding to ensure sufficient FDA personnel are available to clear shipments expeditiously and should develop a Trusted Trader Program to allow shipments from highly compliant importers to be released with minimal documentation or additional information being provided.
- Pharmacy Compounding – The Committee provides an increase of $12,000,000 for pharmacy compounding activities specified in the Drug Quality and Security Act (DQSA). The Committee urges FDA to complete inspections of compounding facilities and take all necessary enforcement actions needed to promote the safety of the drug supply chain.
Senate Bill and Report
There was nothing in the Senate Bill or Report on the generic drug labeling rule. The Senate Appropriations Committee did, nevertheless, express its own concerns about certain drug-related matters:
- Abuse-Deterrent Drug Development – The Committee urged FDA to make faster progress regarding abuse-deterrent opioids and directed FDA to finalize the January 2013 draft guidance on evaluation and labeling of abuse-deterrent opioids. FDA should also publish draft guidance on the assessment of generic versions of such products and address whether human abuse liability studies will be needed.
- Pharmacy Compounding – Like the House, the Senate Appropriations Committee focused upon FDA’s implementation of the DQSA. The Committee directed FDA to meet with stakeholders to ensure continued access to safe compounded drugs for which there is a clinical need.
- Counterfeit Products – The Committee recommendation includes an increase of $4,820,000 to provide FDA with additional resources to investigate counterfeit drugs.
- Import Shipments – Like the House Appropriations Committee, the Senate Appropriations Committee encouraged FDA to improve import clearance procedures and develop a Trusted Trader-type of program.
- Keeping Prescription Drug Inserts In Paper Format – FDA has long sought to develop ways that drug manufacturers could move providing paper-based full product labeling (known as the PI) to electronic labeling. Entering into the fray, the Committee directed FDA to ensure that any proposed regulation preserves the paper PI.
So what’s next?
Our public policy specialists anticipate that the House will take up the Bill next week, with both chambers likely to act within the next two weeks. From there, the Bills will move to a conference to iron out the differences, possibly in July.
As to the Report language we discussed above, typically the conference of the House and Senate will adopt all report items unless otherwise contradicted. It will, therefore, be especially interesting to see whether the final product retains the harsh condemnation of the generic drug labeling rule, and the order that FDA undertake a new economic analysis.
