Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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FDA Defends Expedited Oncology Drug Approvals, Neglects GAO Criticism

FDA Defends Expedited Oncology Drug Approvals, Neglects GAO Criticism | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Richard Pazdur, M.D., Director of the Office of Hematology and Oncology Products, highlights some of his office’s 2015 approvals and discusses a few of the expedited review programs that are used by the office.


In 2015, the Office of Hematology and Oncology Products (OHOP) approved 16 new molecular entities (NMEs). The most notable were drug approvals in disease areas such as non-small-cell lung cancer, colorectal cancer, breast cancer, melanoma, renal cancer, and diseases that are particularly difficult to treat like pancreatic cancer.


FDA reviews new drug applications according to timeframes established by the Prescription Drug User Fee Act (PDUFA). There are also programs in place to expedite the drug development and review timeline, and many of the innovative therapies that were approved by OHOP this past year received an expedited designation. Generally, these designations are given to therapies that we consider to be better than what is currently on the market or that fulfill an unmet medical need. The accelerated approval, priority review, and breakthrough therapy programs are frequently used with new oncology drugs, and often a single drug receives multiple designations.

Pharma Guy's insight:

Dr.. Pazdur notes that "Following an accelerated approval, companies conduct additional confirmatory clinical trials with the drug to further examine its clinical benefit."


He does not mention the GAO report that found "FDA’s data on postmarket safety issues and studies were found to be incomplete, outdated, to contain inaccuracies, and to be stored in a manner that made routine, systematic analysis difficult.": http://sco.lt/898BUn  

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GAO Report: FDA Expedites Drug Approvals, But Its Postapproval Oversight Stinks!

GAO Report: FDA Expedites Drug Approvals, But Its Postapproval Oversight Stinks! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

FDA has supported efforts to shorten development and streamline the agency’s review of drug applications through expedited pathways. However, we found problems with the agency’s efforts to oversee and track potential safety issues and postmarket studies once those drugs are on the market. While internal control standards for the federal government specify that information should be recorded in a form and within a time frame that enables staff to carry out their responsibilities and that relevant, reliable, and timely information should be available for external reporting purposes, FDA’s data on postmarket safety issues and studies were found to be incomplete, outdated, to contain inaccuracies, and to be stored in a manner that made routine, systematic analysis difficult. 


FDA lacks reliable, readily accessible data on tracked safety issues and postmarket studies needed to meet certain postmarket safety reporting responsibilities and to conduct systematic oversight. Tracked safety issues are potential safety issues that FDA determines are significant and that it tracks using an internal database. Internal control standards for federal agencies specify that information should be recorded in a form and within a time frame that enables staff to carry out their responsibilities and that relevant, reliable, and timely information should be available for external reporting purposes. However, evaluations conducted by CDER of data in its database revealed problems with the completeness, timeliness, and accuracy of the data. These problems, as well as problems with the way data are recorded that impair their accessibility, have prevented FDA from publishing statutorily required reports on certain potential safety issues and postmarket studies in a timely manner, and have restricted the agency's ability to perform systematic oversight of postmarket drug safety. Although FDA has taken some steps to address the problems with its data, the agency lacks plans that comprehensively outline its efforts and establish related goals and time frames. Additionally, FDA does not have plans to use these data to inform its oversight of its expedited programs, such as determining if drugs that used an expedited program were subsequently associated with tracked safety issues at rates or of types that differed from drugs that used FDA's standard process.

Pharma Guy's insight:

I reported on this problem back in 2013:


Many drug approvals were fast-tracked on the promise that pharma companies would meet study deadlines and supply the FDA with data about any adverse events discovered via observational postmarketing studies after market approval.

So, how well has the FDA held pharma companies feet to the fire regarding postmarketing commitments under FDAAA jurisdiction?

Not very well at all, according a Research Letter published in the July 10, 2013, issue of JAMA. The authors of the study found that NONE (zero) of the 865 studies under FDAAA jurisdiction from 2008 through 2011 have been completed. Of the 387 studies mandated in 2011, 271 (70%) have not even begun.


For more on that, read "FDA is Lax in Enforcing Law Regarding Prescription Drug Postmarketing Studies"; http://bit.ly/1PoqAsY 

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Pharma Guy's curator insight, March 28, 2016 2:41 PM

I reported on this problem back in 2013:

 

Many drug approvals were fast-tracked on the promise that pharma companies would meet study deadlines and supply the FDA with data about any adverse events discovered via observational postmarketing studies after market approval.

So, how well has the FDA held pharma companies feet to the fire regarding postmarketing commitments under FDAAA jurisdiction?

Not very well at all, according a Research Letter published in the July 10, 2013, issue of JAMA. The authors of the study found that NONE (zero) of the 865 studies under FDAAA jurisdiction from 2008 through 2011 have been completed. Of the 387 studies mandated in 2011, 271 (70%) have not even begun.

 

For more on that, read "FDA is Lax in Enforcing Law Regarding Prescription Drug Postmarketing Studies"; http://bit.ly/1PoqAsY