House Passes Medical Controlled Substances Transportation Act

The House of Representatives has passed legislation that would allow health practitioners to transport controlled substances across state lines. Under H.R. 1492, the Medical Controlled Substances Transportation Act, emergency medical services personnel and sports team physicians could register with the Drug Enforcement Administration (DEA) to transport controlled substances and administer them to patients outside of their registered work places. After 72 hours, the medicines would need to be returned to where they are stored, and doctors would be required to maintain records of where the medication was administered. Schedule I drugs are excluded from the changes in the legislation. H.R. 1492 passed by a
vote of 416-2.

Appropriators Make Progress of FY2018 Spending Bills

Despite the inability of House Republicans to reach an agreement on a fiscal year (FY) 2018 budget resolution, Congressional appropriators made significant progress last week on a number of individual spending bills for the coming fiscal year.

The House Appropriations Committee unanimously advanced a $20 billion spending bill that would give the Food and Drug Administration (FDA) $5.1 billion in total spending for the coming fiscal year, with $2.8 billion derived from taxpayer funding and the remainder funded by user fees. This is an increase of $500 million for the agency over current spending levels. Despite a failed attempt to strike the provision, the appropriations bill reported out by the Committee would would prevent the FDA from requiring retroactive safety reviews of e-cigarettes already on the market. House appropriators also released the FDA report language last week. Lawmakers direct the FDA to loosen policies on compounded medication. The appropriators are concerned that the FDA’s strict interpretation of the Drug Quality and Security Act jeopardizes the availability of compounded medications for office use, which they say was intended to be
allowable under the 2013 law. Additionally, appropriators comment on the definition of distribution of compounded drugs within the State MOU, and express concerns that the agency’s advisory committee on compounded medication does not adequately represent the interests of providers and patients. The report language instructs the FDA to spend $60 million on efforts related to continuous drug manufacturing, and $24.6 million on a medical countermeasures initiative. Instead of finalizing draft guidance on laboratory-developed tests (LDTs), lawmakers tell the FDA to work with Congress on a new regulatory pathway. In order to increase enrollment and retention in cancer clinical trials, particularly for minorities, the FDA is directed to reconsider its guidance on third-party expense payments to research participants.

The House Appropriations Committee also released its Labor/HHS/Education 2018 budget proposal. The bill includes $156 billion in total discretionary spending, $5 billion below the current fiscal year. The U.S. Department of Health and Human Services (HHS) would receive $77.6 billion, $542 million less than current spending levels.

  • The National Institutes of Health (NIH) would receive $35.2 billion in the next fiscal year, $8.6 billion above the President’s request and $1.1 billion over current spending levels. The proposal would require NIH to reimburse grantee research institutes for facility and administrative costs, in opposition of the President’s budget proposal. HHS would not be allowed to cap reimbursements for these overhead costs.
  • The Centers for Disease Control and Prevention (CDC) would receive a total of $7 billion, a decrease of $198 million compared to the current fiscal year, but a much more modest cut that than contained in the President’s budget. The bill includes $1.45 billion for the CDC’s Public Health Preparedness and Response programs, an increase of $45million.
  • The Centers for Medicare and Medicaid Services (CMS) would receive $3.5 billion, $219 million less than FY2017, and $127 million below the FY2018 budget request.
  • The Substance Abuse and Mental Health Services Administration (SAMHSA) would be funded at $3.5 billion, $306 million below current levels but $68 million above the President’s request.
  • The Office of the National Coordinator (ONC) would receive $39 million in funding, totaling a 35 percent cut, in line with the Administration’s budget request.
  • The Agency for Healthcare Research and Quality (AHRQ) would be cut by $24 million, but would be maintained as a standalone agency. The Administration had proposed making AHRQ a part of NIH.

The bill would prohibit the use of any new discretionary funding to implement the Affordable Care Act (ACA). The spending bill was advanced out of Subcommittee by a vote of 9-6, and will be marked up by the full Appropriations Committee on July 19.

In the Senate, appropriators advanced their first FY 2018 spending bill, unanimously approving appropriations for Military Construction and Veterans Affairs. The bill includes $88.9 in discretionary funding, $246 million below the President’s request but $1.8 billion above current spending levels. The Department of Veterans Affairs (VA) would receive $78.4 billion in appropriations, a $4 billion increase over current spending.

In related news, Minority Leader Chuck Schumer (D-N.Y.) has issued a warning to House Republicans that inclusion of money for the construction of a border wall in FY 2018 appropriations could lead to a government shutdown. The House Homeland Security spending bill would appropriate $1.6 billion for such purpose.

The Congressional Budget Office (CBO) also released its report on the President’s budget last week, and found that a $720 billion deficit would remain within the next decade. The Administration has claimed that its plan would result in a surplus by 2027.

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