FDA ConneKTion

Timely updates and insights on the latest issues affecting FDA-regulated companies from Kilpatrick Townsend

Archive for July 2017

Posted on Tuesday, July 25 2017 at 2:24 pm by -

FDA Issues New Guidance on IRB Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations

By: Carolina M. Wirth

As July comes to an end, the Food and Drug Administration (FDA or agency) has issued a new guidance document for “immediate implementation” entitled “IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More than Minimal Risk to Human Subjects.”  The guidance document outlines FDA’s new enforcement policy with regard to IRB waivers or alterations of informed consent requirements for certain minimal risk clinical investigations.

According to FDA, the agency has received numerous inquiries over the years “from sponsors and investigators about conducting important minimal risk clinical investigations for which obtaining informed consent was not practicable[i].” However, FDA did not have the statutory authority to allow for a waiver of informed consent for these types of investigations until the recent passing of the 21st Century Cures Act (Cures Act).

The Cures Act, which was signed into law on December 13, 2016, amended the Federal Food, Drug and Cosmetic Act and provided FDA with the authority to “permit an exception from informed consent requirements when the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject.[ii]”  Currently, FDA regulations only allow an exception from the informed consent requirements in life-threatening situations (21 CFR 50.23) or for emergency research (21 CFR 50.24).  Thus, FDA intends to publish regulations to reflect this statutory change, including any appropriate human subject protection safeguards.

Until the new regulations are published, FDA does not “intend to object to an IRB approving a consent procedure that does not include, or that alters some or all the element of informed consent set forth in 21 CFR 50.25,” as long as the IRB finds and documents that:

  • The clinical investigation involves no more than minimal risk (as defined in 21 CFR 50.3(k) or 56.102(i)) to the subject;
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  • The clinical investigation could not practicably be carried out without the waiver or alteration; and
  • Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

According to FDA, it intends to “withdraw th[e] guidance after [it] promulgate[s] regulations to permit a waiver or alteration of informed consent under appropriate human subject protection safeguards consistent with Section 3024 of the Cures Act.[iii]”  However, the agency does not provide a timeframe for when it plans to issue these regulations.  In the meantime, while the guidance is for immediate implementation, the agency “will consider all comments received and will revise this guidance when appropriate.[iv]


[i] Guidance at 1.

[ii] Guidance at 2.

[iii] Guidance at 4.

[iv] Guidance at 2.

Posted on Wednesday, July 12 2017 at 9:19 pm by -

The Deadline for Submitting Comments to USDA as it Prepares to Draft a Proposed Rule on GMO Labeling is Quickly Approaching – Submit your Comments Now.

On June 28, 2017, the U.S. Department of Agriculture (USDA or agency) Agricultural Marketing Service (AMS) posted a list of 30 questions for consideration by stakeholders in order to assist the agency in developing a Proposed Rule setting national standards and procedures for the labeling of bioengineered foods  (i.e., GMO labeling).

As you may recall, AMS has two years to implement the National Bioengineered Food Disclosure Standards Law which was enacted by Congress on July 29, 2016, and charged the agency with developing a national mandatory system for disclosing the presence of bioengineered material in foods. The law also preempted future and existing state laws attempting to establish GMO labeling requirements for foods containing bioengineered materials. See our previous blog post on the Vermont GMO Law here.

With about a year left to publish a final rule (AMS is mandated to publish a final rule by July 2018), AMS is publishing this list of questions in the hopes that it will use any input to draft the proposed rule. The questions cover an array of topics from the terms that AMS should consider as interchangeable with “bioengineering,” to the text that manufacturers should be required to use when it chooses to use text to disclose a bioengineered food.

AMS is only providing stakeholders until Monday, July 17, 2017 to submit any comments.  Comments may be submitted to the following email address: GMOlabeling@ams.usda.gov.

Interested parties will also have an opportunity to submit any comments once a proposed rule is published by AMS. We will be closely following this rulemaking, as it may directly impact the compliance deadline for the new Nutrition Facts Label and Serving Size Final Rules published by the Food and Drug Administration in May 2016.  FDA recently indefinitely delayed the compliance date for these Final Rules (see our blog post here), and that decision may have been in part in order to avoid having industry update food labels twice within a short period of time.