The FDA should publish a rulemaking notice on the roles that third-party companies play in the security of the nation’s drug supply “without delay,” the House Appropriations Committee said ahead of a vote on the agency’s fiscal year 2020 budget.
The committee marked up the agency’s nearly $3.3 billion budget—$185 million more than the White House’s request.
Despite the proposed budget hike, the committee made clear that it’s losing patience with the agency over the Drug Supply Chain Security Act (DSCSA). The committee said the agency “is more than three years late in meeting its statutory obligation to establish a Federal licensing standard for third-party logistics providers and wholesale distributors. This provision was intended to set federal standards to govern licensing for all third-party logistics providers and wholesale distributors, helping to strengthen FDA’s and states’ ability to ensure the security of the drug supply chain.”