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Jill Wechsler is Pharmaceutical Technology's Washington Editor, firstname.lastname@example.org.
The Senate approved a $159-million budget increase for FDA, to bring its resources up to $5.4 billion for 2019, including more than $2 billion in user fees.
Instead of taking the usual August recess, the Senate stayed in Washington to approve several multi-agency budget bills for the government fiscal year that begins Oct. 1, 2018. The measures boost funding for FDA and the National Institutes of Health (NIH) and include a contentious provision that requires biopharma companies to disclose product prices in direct-to-consumer (DTC) advertising.
The DTC ad measure was added to a major Senate appropriations bill for the Departments of Labor, Education, and Health and Human Services (HHS). That legislation provides a $2.3-billion increase in NIH funding, to $39 billion, with some of that money directed to combat the opioid epidemic by supporting NIH research to develop non-addictive pain therapies.
Most notable is an amendment that aims to provide consumers with more information on drug costs by instructing HHS to develop and implement rules requiring manufacturers to list drug prices in ads. This provision most likely will involve a formal rulemaking process to clarify what information (e.g., list or discounted prices) should be disclosed and how the policy would be implemented.
In another major funding bill for the Department of Agriculture and other agencies, the Senate approved a $159-million budget increase for FDA, to bring its resources up to $5.4 billion for 2019, including more than $2 billion in user fees. The Senate plan, though, provides much less than the $400-million hike for FDA requested by the administration, and is well below the $308-million boost approved by House committees. The Senate provides FDA an additional $88.5 million to enhance medical product development and oversight, compared to $260 million proposed in the House, with the added funds directed to advance drug and medical device manufacturing, modernize general drug development, and support new science to evaluate drugs.
Senate leaders hope that their House colleagues will agree to negotiate final funding packages through conference committees, instead of waiting for formal House approval of separate budget bills. All parties want to finalize these spending bills before October 1, 2018 when the government could shut down without approved funding for the 2019 fiscal year. Pharma companies seek to remove the price disclosure provision, while advocates for sufficient FDA resources, such as the Alliance for a Stronger FDA, are working to gain final funding closer to the higher House proposals.