Lawmakers issue new draft proposals for sharing off-label data

House lawmakers issue new draft proposals for sharing off-label data
House lawmakers issue new draft proposals for sharing off-label data

A new discussion draft was issued by House lawmakers in late April proposing several legislative changes that would drastically alter drug development and the delivery processes. The lawmakers issued the draft as part of a legislative initiative developed by House Representatives Fred Upton, R-Mich., and Diana DeGette, D-Colo., called the 21st Century Cures. The first discussion draft was revealed in January 2015. However, many of the proposals in that draft were rejected before the release of this document.  

New draft introduced proposals
One of the many proposals that the new draft makes is increasing the funding for the National Institutes of Health. Other suggestions included creating a priority review program for specific medical breakthrough devices and updating the search tools on ClinicalTrials.gov. The draft also recommended that the U.S. Food and Drug Administration be required to develop a basic strategy to examine patient experience data within regulatory decision-making processes. 

Pharmaceutical businesses are currently prohibited by law from sharing economic data with the health care sector, as it's considered off-label. If the proposal is approved, it would enable drugmakers to share this information with formulary groups and payers for the first time. 

Draft proposes modernized requirements
As a part of the draft, PhRMA proposed alterations to the regulations currently in place by the FDA regarding product communication, stating that these rules must be modernized.

"We share the committee's interest in modernizing the FDA's regulation of healthcare communication to ensure healthcare providers have access to scientifically accurate and up-to-date information in order to achieve the best possible outcomes for patients," PhRMA President and CEO John Castellani said in a statement, according to Medical Marketing & Media.

In 2014, the Centers for Medicare and Medicaid Services updated the requirements for which CME payments have to be reported to the Open Payments database. Officials from the CME Coalition approved of the decision to omit the CME payments from the Sunshine Act's reporting requirements.