January 7, 2015

Health and Human Services (HHS) proposes additional requirements for drug makersThe Department of Health and Human Services (HHS) has published a proposal that, if adopted, would require drug makers to submit more information to regulators during clinical trials. HHS’ Notice of Proposed Rulemaking (NPRM) seeks to expand the statistical reporting that pharmaceutical companies must submit during clinical drug trials. The proposal was published in the Federal Register on Nov. 21, 2014. If adopted, drug makers would be required to provide additional disclosure about dangerous drugs and their adverse health impact on users.

Clinical trials for new medications are currently governed by the Food and Drug Administration Amendments Act of 2007 (FDAAA). Under the FDAAA, only two tables of adverse events must be reported.  One table comprises all adverse events experienced by trial participants, while the other shows adverse events occurring with a frequency greater than 5%.  The HHS proposal seeks to mandate the following additional data:

  • Time when the data was collected
  • How the data on adverse reactions was collected
  • Any and all deaths which occurred during the trial
  • Whether the medication caused the adverse events

The proposal wants the collection of this data to assist researchers in comparing the frequency and causes of adverse events. The HHS proposal also seeks to require that researchers publish results of unapproved medications and that those results be made public. With this information, HHS hopes to eliminate public bias created by selective disclosure of medical trials, assist researchers and patients in making an assessment of the pros and cons of a whole class of medication, avoid duplicate studies of harmful or ineffective medications, and to better inform potential trial participants of potential risks in future medical studies.

The NPRM set forth by the HHS asks for certain terms and measurements to be specifically defined in trial reports.  The HHS currently believes terminologies are too vague to assist readers in properly assessing how data was measured and what was the outcome.

The FDAAA of 2007 was an important piece of legislation and the new HHS proposal seeks to further empower patients, researchers, and study participants in determining whether a medication is safe to take.  By collecting more data, the NPRM hopes to better track the progress of clinical trials and strengthen public understanding of clinical results.