Life Science Compliance Update

January 02, 2018

Gottlieb Announces Medical Device Approval Process Update


FDA Commissioner Scott Gottlieb announced in a blog post the agency would be updating its medical device approval processes in order to accommodate rapidly advancing technologies. He described the modernization of FDA’s review framework would include the addition of a voluntary, alternative pathway for demonstrating substantial equivalence, and allow more flexibility to use modern criteria as the reference standard. Additionally, the new pathway will permit comparisons to standards that more closely approximate the kind of novel technology being evaluated. The new framework will be offered in addition to the current 510(k) pathway.


As established in the Medical Devices Amendments of 1976, manufacturers of new, moderate-risk devices must demonstrate substantial equivalence to a similar device legally marketed in the U.S. in order for a new device to be cleared by the FDA. The older devices acting as a comparator are called the predicate devices. This process is often known as the 510(k) pathway. However, this framework has not changed significantly in 40 years. Because the predicate devices that new products must compare themselves to may be up to 40 years old, it creates a burden for 510(k) applicants as newer devices have more advanced technologies. This makes it difficult to identify suitable predicate devices in order to conduct testing.

Modernizing 510(k) Review

Gottlieb announced that FDA will be publishing a draft guidance outlining a voluntary, alternative pathway for demonstrating substantial equivalence in the first quarter of 2018. “This pathway will allow more flexibility to use more modern criteria as the reference standard, and permit comparisons to standards that more closely approximate the kind of novel technology we’re being asked to evaluate.”

The new program allows device manufactures to demonstrate substantial equivalence by meeting safety and performance criteria. It would be available for pre-specified categories of devices and will be outlined in further FDA guidance. The program will also be voluntary and manufactures may still use the existing 510(k) pathway.

Pre- and Post-Market Requirements

Gottlieb notes the balance between “acceptable uncertainty” in the pre-market setting, relative to a product’s benefits and risks, and ultimately how much FDA can rely on post-market follow-up studies, has not been objectively defined in a framework by the agency. He reiterates the early 2018 guidance that will set forth factors the agency may consider when assessing acceptable uncertainty. It will also outline how issues may be resolved in the post-market setting, rather than the pre-market setting which will allow patients faster access to devices. He further notes several factors relevant to the assessment performed by FDA in its pre-market uncertainty review.

Other Policy

FDA also published a list of pending device-related guidance documents. Several of the guidance documents include the application of least burdensome and the Q-Submission program. According to Gottlieb, this “further demonstrate[s] FDA’s commitment to advancing modern regulatory policies that are designed to promote medical device innovation, while continuing to assure the safety and effectiveness of new products.”

December 27, 2017

OPDP Letters Remain on Decline


The Office of Prescription Drug Promotion (OPDP) is known for monitoring company communications about medical products and when it considers those communications to be outside of regulatory parameters, issuing a letter warning the company of such promotion. For relatively minor violations, OPDP issues an Untitled Letter; for more serious violations, OPDP will issue a Warning Letter. 

As can be seen in the below graph, in the late 1990s, OPDP was issuing over 100 Warning and/or Untitled Letters annually. Since that time, there have been peaks and valleys when it comes to the number of Letters issued. Nothing compares to the recent years of 2014 through present, though. In 2014, OPDP issued ten Letters; in 2015, nine Letters; and in 2016, eleven Letters.


For 2017, though, there have only been three letters issued: two Warning Letters and one Untitled Letter. Interestingly, last year followed a similar path up to this point. Very few Letters were issued through October 2016, and then during the last two months of the year, issued more Letters than it had all year. Therefore, it is hard to predict that we will see another year of single-digit Letters issued by OPDP, but it may be possible.

This seeming lack of enforcement from OPDP is important to industry because the letters provide insight into the way the Food and Drug Administration (FDA) is currently thinking about developments in communication. This helps to fill in the gaps between guidances and can help when today’s communications environment is fast pace and quickly-changing.

The trickle of visible enforcement raises questions as to why there has there been a drop in enforcement activity and whether the drop represents a shift in emphasis or new policy? 

This year, Amherst Pharmaceuticals, LLC and Magna Pharmaceuticals, Inc., received a Warning Letter on November 14, 2017, regarding Zolpimist and the way it was advertised online and at an exhibit booth. OPDP took issue with false or misleading claims about the risks associated with, and the efficacy of, the drug. OPDP also noted that the materials were not submitted at either the time of initial dissemination or publication as is required under the Code of Federal Regulations.

Cipher Pharmaceuticals, Inc., received a Warning Letter for CONZIP in August 2017 for its professional detail aid being “false or misleading because it omits important risk information associated with the use of ConZip” within the FD&C Act.

Orexigen Therapeutics, Inc., received 2017s only Untitled Letter for CONTRAVE in May 2017 for a television ad that made false or misleading representations about the risks and side effects associated with Contrave.

It is possible that this drop in Letters shows that the FDA is shifting its focus in enforcement to areas where there is greater risk, as there have been several Letters issued about violations that leave some wondering what the element of risk involved is.

December 20, 2017

FDA to Host Meeting on Opioid Prescribing Information Implementation


On January 30, 2018, the United States Food and Drug Administration (FDA) will host a public meeting entitled, “Opioid Policy Steering Committee: Prescribing Intervention – Exploring a Strategy for Implementation.” The FDA hopes to receive stakeholder input on how the agency can improve the safe use of opioid analgesics by curbing overprescribing to decrease the occurrence of new addictions and limit the misuse and abuse of opioids, under the FDA Risk Evaluation and Mitigation Strategy (REMS).

Recent studies suggest that prescriptions for opioid analgesics are frequently dispensed for a number of tablets that exceed those needed for adequate pain control, particularly for acute pain. The Steering Committee is considering whether current prescribing patterns are contributing to the development of new addiction in patients, and whether the excess unused pills are a gateway to misuse, abuse, and addiction among family members and others who might have access to the unused pills. Therefore, the Steering Committee is exploring the option of simplifying prescribing by requiring sponsors to implement a prescriber intervention at the point when the prescriber determines an opioid analgesic prescription is necessary for a patient.

The Steering Committee's view is that sponsors could implement this type of prescribing documentation requirement through an electronic system incorporated into the prescriber's workflow to minimize the burden on patient access and on the health care delivery system. Thus, the Steering Committee is interested in exploring evidence-based approaches that would encourage electronic prescribing as a mechanism for the prescriber to provide documentation of a safe-use condition before the drug is dispensed by the pharmacy. The Steering Committee also seeks input from the public on alternative REMS models or approaches for consideration.

The FDA is focused on several main questions, including:

  1. If a REMS were to specify threshold drug amounts for opioid analgesic prescriptions above which prescribers would be required to provide additional documentation of medical necessity, what should the amounts be and how should they be determined for various clinical indications? What data are there to support such amounts? What additional data would be useful?
  2. If such measures were required, how should prescribers be made aware of them? Within the Agency's statutory REMS authority, how should the Agency require sponsors to ensure compliance with them? How should the Agency require sponsors to assess their effect in reducing misuse, abuse, and new addictions?
  3. The Steering Committee requests input from the public on whether, in addition to, or in conjunction with the above described prescriber intervention, and to the extent consistent with its statutory authority, the Agency should consider requiring sponsors to create a system that utilizes a nationwide prescription history database to facilitate safe use of opioid analgesics.
  4. If this approach were adopted, how should the Agency require sponsors to assess the impact of such requirements?

FDA is seeking feedback from a broad group of stakeholders, both private and public, who are working on the challenges of improving pain management while addressing the opioid epidemic. The Agency is also particularly interested in ensuring that any REMS intervention minimizes the burden on patient access and, to the extent practicable, on the health care delivery system. Relevant questions for consideration are provided below.

For comments on the topic, you can submit written submissions to the Dockets Management Staff (HFA-305). All submissions received must include the Docket No. FDA-2017-N-6502 for “Opioid Policy Steering Committee: Prescribing Intervention—Exploring a Strategy for Implementation; Public Hearing; Request for Comments.” Comments filed in a timely manner, will be placed in the docket and, except for those submitted as “Confidential Submissions,” be publicly viewable at or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

If you wish to attend this meeting, and/or present at the meeting, you need to register with the Agency by January 16, 2018.


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