FDA decisions on treatments for gastrointestinal disorders

Rebecca Aris interviews Lisa Kubaska

FDA spokesperson

In our gastrointestinal disease focus month, we speak with FDA spokesperson, Lisa Kubaska on how the FDA reaches decisions on treatments in this area.

The role of the Gastrointestinal Drugs Advisory Committee (GIDAC) is to review and evaluate available data ‘concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of gastrointestinal diseases and makes appropriate recommendations to the Commissioner of Food and Drugs’.¹

We spoke with Lisa Kubaska, spokesperson for the FDA, about GIDAC’s contribution to the FDA’s decision making in this therapeutic area and how GIDAC make its decisions.

Interview summary

RA: Can you please tell us about the role of GIDAC?

LK: The primary role of GIDAC is to provide independent advice on human drug products for use in the treatment of gastrointestinal diseases that will contribute to the quality of the agency's regulatory decision-making and lend credibility to the product review process. In this way, the FDA can make sound decisions about new drug products and other public health issues. And although advisory committees have a prominent role in the product approval stage, they are sometimes included earlier in the product development cycle and are asked to consider issues relating to products already on the market.

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"In this way, the FDA can make sound decisions about new drug products and other public health issues."

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RA: How does GIDAC contribute to FDA’s decision on the safety and efficacy of a new GI drug?

LK: The committee typically is asked to comment on whether adequate data support approval. They also may recommend that the FDA request additional studies or suggest changes to a product's labeling. It is important for the committee to have members with different perspectives and expertise to give balance to the discussions and final recommendations.

RA: What GI treatments have GIDAC recently recommended for approval and why?

LK: The committee voted in favour of the benefit-risk profiles for 1) Humira for the treatment of patients with moderately to severely active ulcerative colitis and 2) teduglutide for patients with Short Bowel Syndrome, based on the data presented.

RA: What GI treatments have GIDAC recently not recommended for approval and why?

LK: There have not been any in 2012.

RA: How long does it take to determine whether a drug should be recommended for approval or not?

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"Understanding the molecular and pharmacogenomic basis of gastrointestinal and hepatic diseases will lead to development of novel treatments..."

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LK: The timing of FDA’s decision is based on the PDUFA goal dates.

RA: How likely is it that the FDA will agree with GIDAC's decision?

LK: GIDAC’s recommendations do not bind the agency to any decision. While committee discussions and final votes are very important to the FDA, the final regulatory decision rests with the agency.

RA: What advances in GI treatments do you expect to see over the next five years?

Understanding the molecular and pharmacogenomic basis of gastrointestinal and hepatic diseases will lead to development of novel treatments for diseases that currently have no therapeutic options. Diseases including inborn errors of metabolism, NASH, primary biliary cirrhosis and others lead us to be expectant of novel treatments for the management of these diseases.

References

1. FDA advisory committees: – http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/GastrointestinalDrugsAdvisoryCommittee/default.htm

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