Despite bemoaning inadequate funding caps and the impact of sequestration, the Senate Appropriations Committee unanimously voted Thursday to favorably report its fiscal 2018 spending bill for the FDA and U.S. Department of Agriculture to the full Senate. The bill provides $2.8 billion in discretionary funding for the FDA, which is $1 million more than the fiscal 2017 enacted level. Total FDA funding, including user fee revenue, is $5.2 billion – $491 million more than this year. The bill includes $60 million as authorized by the 21st Century Cures Act. Voting along party lines, the committee rejected, 16-15, a proposal by Sen. Patrick Leahy (D-Vt.) to increase nondefense discretionary spending $54 billion above the post-sequester spending caps mandated by the Budget Control Act, in keeping with a proposed bump in defense spending. The committee also rejected, again along party lines, an alternative Agriculture-FDA spending plan offered by Sen. Jeff Merkley (D-Ore.) as a "conversation starter" of what appropriators could do if their hands weren't tied by arbitrary spending caps. Under that plan, the FDA would have received $100 million more to enhance drug and device safety and further implement the Food Safety and Modernization Act. "It would always be nice to have more resources," responded Sen. John Hoeven (R-N.D.), chairman of the Appropriations subcommittee that assembled the approved spending bill, which he described as fair and balanced. Leahy, the vice chairman of the full committee, congratulated his colleagues on both sides of the aisle for rejecting poison pill policy riders and the "misguided administration cuts" that would require user fees to fund a larger share of the FDA budget. Sen. Lamar Alexander (R-Tenn.) stressed the importance of the Senate completing its work on the bill so it, rather than the House or president, could establish the spending priorities. (See BioWorld Today, July 20, 2017.)

The FDA Thursday announced the availability of the Supply Chain Security Toolkit for Medical Products. The toolkit, which focuses on developing and implementing processes and procedures to enhance global medical product quality and supply chain security, is the culmination of a four-year collaboration with regulators from the Asia-Pacific region, industry, international organizations and academia. In another supply chain effort, the FDA is planning a voluntary pilot program, under the 2013 Drug Supply Chain Security Act (DSCSA), to help develop an electronic, interoperable system to identify and trace certain prescription drugs as they're distributed in the U.S. The agency also plans to hold a series of public meetings to get stakeholder input on strategies and issues related to the enhanced security provisions in DSCSA. The first meeting, set for Aug. 23, will consider what the supply chain is expected to look like in 2023 and enhanced security needs. A second meeting will be held Dec. 5-6 to discuss interoperability standards, data exchange standards, data architecture, and aggregation and inference. Topics for the final meeting, set for Feb. 28, are further refining of enhanced drug distribution security needs and building capacity for a unit-level system. The schedule for registering to participate in the meetings and submit written comments is available in a notice published in Thursday's Federal Register. Earlier this month, the FDA released draft guidance granting a one-year grace period before it enforces a DSCSA provision requiring drug manufacturers to label their drugs with a product identifier.

Baxter International Inc., of Deerfield, Ill., and Claris Lifesciences Ltd., of Ahmedabad, India, agreed to divest all of Claris' rights to fluconazole in saline intravenous bags and milrinone in dextrose intravenous bags to New Jersey-based Renaissance Lakewood LLC. As part of the proposed agreement, Baxter would supply Renaissance with fluconazole and milrinone for up to five years while transferring the manufacturing technology to Renaissance or its contract manufacturer. Baxter also would be required to help Renaissance establish its manufacturing capabilities and secure the necessary FDA approvals for the generic drugs. The settlement is intended to resolve Federal Trade Commission (FTC) charges that Baxter's proposed $625 million acquisition of Claris' injectable drugs business is anticompetitive. The FTC claimed the acquisition would reduce generic competition for the two drugs in the U.S. from four potential suppliers to three, likely resulting in higher prices. The agreement is subject to public comment, which is due by Aug. 21.

Manuel Pena, of Houston, was sentenced Wednesday in federal court to 15 months in prison, followed by two years of supervised release on his conviction of conspiracy to import prescription drugs into the U.S. from India. Pena was accused of conspiring to misbrand, smuggle and import the drugs from about November 2013 until January 2015, according to the U.S. Department of Justice.