IntroductionThis section presents attorneys with an insider’s view of FDA-regulated industry. It explains information
you must know to be more insightful and effective in supporting your client.
Advice to Attorneys Seeking Documents During Discovery
Dr. Sharlin often assists attorneys in FDA-related cases to identify documents to obtain during discovery. This effort has two parts. First, legal and regulatory aspects and second, information exchange between companies and FDA. For the legal and regulatory aspects, the cornerstone is the requirement that companies follow FDA mandates as defined in the Code of Federal Regulations (CFR). It is this documentation required by FDA to prove compliance, that should be sought during discovery.
Attorneys should follow three steps:
(1) Identify FDA-related legal issues. For example, failure to warn patients, deficient
submission content, or withholding information from FDA.
(2) Determine the relevant regulations. For example, content of a 510(k) submission (21
CFR 808.87), medical device safety reporting requirements (21 CFR 803), or
postmarketing reporting of adverse drug experiences (21 CFR 314.80).
(3) For each regulation, ask for the FDA required documentation that proves compliance.
This has three parts; a standard operating procedure (SOP), documentation that the SOP
was followed, and evidence of the process being evaluated by an independent quality
assurance unit (QAU). All companies maintain a list of their SOPs and this document
should be among the first requested during discovery. Regarding information exchange with FDA, key facts in a case often exist in information sent to, or received from FDA. Examples include; product submissions, minutes from meetings and phone calls, responses to questions from FDA, Annual Reports, and emails. It’s also possible that company interactions with clinical sites during a study may be important. Be aware it’s common for companies to outsource work to a contract research organization (CRO). Therefore, documentation sought during discovery may be in the possession of one or more CROs.
Errors Caused by OutsourcingAlmost all FDA-regulated companies outsource work to other businesses, called CROs (Contract
Research Organizations). CROs perform a wide variety of activities including, drug/device development
and manufacturing, clinical trial execution, writing the FDA submission, and conducting post-approval
studies. Some FDA-regulated companies are completely virtual, all work is outsourced to CROs. Conflicts
between an FDA-regulated company and its CROs are common. Attorneys should be aware that this
potentially antagonistic relationship can be a source of error with regard to collecting and analyzing all
types of information. Attorneys should examine emails between the two organizations for evidence of
mistakes. Also review the work performed by the FDA-regulated company’s quality department that
describes a CRO’s errors and evaluates actions (or lack of action) taken by the CRO to fix their mistakes.
Mistakes in Clinical TrialsAttorneys should be aware of a known and accepted truth in the FDA-regulated industry; all clinical trials
have errors. Because clinical trials are complex, and many parties are involved, mistakes happen.
Examples of mistakes include; incorrect dosing of study drug, wrong data is collected, a scheduled data
collection is missed, or an error occurs in aggregating data for analysis. One key to being insightful about a case is to identify study errors, learn their cause, and understand their effect on study results and conclusions about safety and effectiveness.