All Things Regulatory: Is Bad Data Behind Pharma’s Negative Image?

September 3, 2015 YourEncore Marketing


Once among the most admired industries, pharmaceutical companies today have reputations that rival those of banking and the airline industry. Why does an industry that has such a noble mission and saves lives have such a negative and much-assailed reputation?

Some of the criticism is understandable, including the high cost of some drugs, direct-to-consumer marketing and prominent lawsuits about “dangerous” drugs.

Some is unjustified; big pharma is ripe for those who favor regulations. The upcoming 2017 PDUFA renewal negotiations may not be good news for the industry in this regard as critics assault the integrity of the industry with the goal to include renewal provisions that will impose more restrictions on industry activities.

Data is Key

Much of the criticism of the pharmaceutical industry finds its origin in poor access to data, leading to drug recalls and false scares. The industry hasn’t been great at sharing data that can help improve patient safety and track potential issues. With cloud technology, it should be easier to share clinical trial and other drug development data, potentially yielding more observations to improve care practices as well as trial designs.

A good start is the Food & Drug Administration’s Safety First initiative, which requires pharmaceutical companies to conduct post-market safety monitoring and review such data for trends and other potential learning. Sentinel gives the FDA a powerful new tool to track the safety of drugs, biologics and medical devices once they reach the market.

Biopharma companies also are looking to the broader adoption of biomarkers for regulatory approvals and surveillance, such as predictive toxicology biomarkers that have recently been embraced by the FDA. These biomarkers (blood and other tests) have the potential to predict patient responses to a drug over time, making trials more efficient.

The pharmaceutical supply chain also will benefit from better data sharing. Counterfeit and substandard drugs penetrating the U.S. border, and raw materials used in drug production coming from overseas introduce appreciable risk into the market. Some of these risks, especially from substandard medications, won’t be known for years until their effect (or lack of effect) becomes apparent. Better tracking of these agents and raw materials will provide important information to help the industry improve safety and quality.

For more information about trends around accessing data in pharma, download our eBook, “The Pharm-ers Almanac.


Authored by: Tim Franson, M.D., Chief Medical Officer at YourEncore; former VP Global Regulatory Affairs & Patient Safety, Eli Lilly and Company.

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