USDA and FDA Announce Intent to Improve and Increase Coordination and Collaboration

USDA and FDA Announce Intent to Improve and Increase Coordination and Collaboration

By Riëtte van Laack

Thanks On January 30, 2018, Dr. Gottlieb of FDA and Secretary Perdue of the USDA announced that they had signed a formal agreement to make the coordination and collaboration between the two agencies more efficient and effective.

The USDA has jurisdiction over most meat, poultry, catfish, and certain egg products whereas FDA has jurisdiction over all other foods such as dairy, seafood, produce and packaged foods. Over the years, the two agencies have worked together and made agreements about information sharing, e.g., a Memorandum of Understanding (MOU) from 1999 concerning information sharing about establishments and operations that are subject to dual jurisdiction and an MOU from 2000 concerning review of ingredients intended for use in products under USDA jurisdiction.

The purpose of the January 30, 2018 formal agreement is to “document and formalize ongoing coordination and collaborative efforts between the USDA and the FDA relative to issues of shared concern.” The agreement specifically calls out the issues of dual-jurisdiction facilities, produce safety, and the regulation of biotechnology products.  As far as dual jurisdiction facilities are concerned, “USDA and FDA share the goals of identifying and potentially reducing the number of establishments subject to the dual regulatory requirements of USDA and FDA, bringing greater clarity and consistency to jurisdictional decisions under USDA and FDA’s respective authorities, including transition period, and decreasing unnecessary regulatory burdens.”  Although this likely comes as good news for such facilities, the agreement seems a statement of intent and does not provide details as to how the agencies anticipate accomplishing their goals.

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Join Us in April to Learn More about Improving Regulatory Compliance While Minimizing Products Liability!

Join Us in April to Learn More about Improving Regulatory Compliance While Minimizing Products Liability!

By Hyman, Phelps & McNamara, P.C.

The fact is, regulatory compliance has an impact on products liability.  Yet, the two are seldom considered together.

We aim to change that with a special day and a half program (April 12th and 13th).  Our FDA regulatory firm has teamed up with a renowned medical device liability insurer, MEDMARC Insurance, for a joint program.  It will be held at Virginia Tech’s state-of-the-art conference facility in Arlington, Virginia.

Based upon years of claims experience, MEDMARC has identified the specific FDA regulatory areas that pose the most products liability danger.  We will teach you about improving regulatory compliance in those areas.  MEDMARC will help you understand how to reduce products liability risks.  The combination of these two topics creates a synergy that adds up to powerful risk management.

So give yourself a competitive advantage!  Learn the ounce of prevention that will save you many tens of thousands of dollars every time your FDA inspection goes right or a costly products liability lawsuit is prevented.

All the key program details are in the conference brochure.  You can register here for the conference.

We can’t wait to see you this April to share what we know about mitigating the “other risks” associated with government regulation.

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Vape Shops Challenge Constitutionality of FDA’s Deeming Rule

Vape Shops Challenge Constitutionality of FDA’s Deeming Rule

By Ricardo Carvajal & David B. Clissold & JP Ellison

Vape shops in several states have banded together in litigation challenging the constitutionality of FDA’s Deeming Rule (for background information on that regulation, see our prior posting here). Plaintiffs are pursuing the litigation simultaneously in several federal district courts – perhaps with the objective of accelerating the emergence of any potential split in the lower courts that would enhance the chances of obtaining Supreme Court review.

The complaints (see here, here, and here) allege that the Deeming Rule violates the Appointments Clause of Article II because it was issued by an FDA employee who lacked the authority to do so. According to Plaintiffs, “[b]ecause the issuance of a rule is final, because a rule binds the government and the regulated public, and because a rule cannot be easily reversed, only a principal officer of the United States—one who has been nominated by the President and confirmed by the Senate—may exercise such authority” (emphasis added). Plaintiffs acknowledge that the Appointments Clause permits Congress to “vest the appointment of ‘inferior Officers… in the President alone, in the Courts of Law, or in the Heads of Departments’” (emphasis added). However, Plaintiffs argue that, even if an inferior officer can issue a rule such as the deeming regulation, “mere agency employees may not.”

The complaints further allege that the Deeming Rule violates the First Amendment by imposing “significant restrictions on truthful, non-misleading speech” in relation to modified-risk tobacco products. The use of a claim to the effect that a given tobacco product presents a lower risk of harm than a commercially marketed tobacco product must first be approved by FDA pursuant to a showing that the given product “will… significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and… benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.” Even a “reduced exposure” claim, such as a claim that vaping liquids do not have several carcinogens found in cigarettes, requires FDA’s preapproval. Plaintiffs contend that this “imposes an extraordinary prior restraint” on manufacturers and retailers, in that it’s not enough to show that the speech in question is truthful; in addition, one must show that the “truthful speech will create a net benefit.” The Deeming Rule thereby “impermissibly inverts the constitutionally required burden of proof, under which the government, not the speaker, must demonstrate that a restriction on speech directly and materially advances a valid interest asserted by the government” (emphasis in original).

Given the filing of similar complaints in multiple jurisdictions, we would not be surprised to see the government first try to get the cases consolidated (or at least coordinated). We look forward to seeing how the government eventually addresses Plaintiffs’ allegations.

While we’ve seen variations on the First Amendment argument with some frequency in a number of recent FDA cases, the Appointments Clause argument appears to be an issue of first impression in the FDA space.  Significantly, the theory is not limited to the regulations at issue in the case.  If successful, by logical extension it would implicate thousands of FDA regulations.  The statute of limitations for suits against the government may limit the number of affirmative suits challenging regulations to those issued in the past 6 years (28 USC 2401), but nothing would prevent regulated entities from raising this argument as a defense in an FDA enforcement action based on a “defective” regulation.  That said, it’s not clear how a “win” for the plaintiff in this case would play out.  The Appointments Clause argument, if successful, would seem to only invalidate the issuance of the final rule (not, by way of contrast, the notice and comment process).  Presumably, FDA could, without much difficulty, re-issue any affected final rules in short order—if it wanted to do so.  The administration could only re-issue some regulations, however.   In addition to any filings in this action, we’ll also be watching to see under whose authority FDA’s next final rule is issued.

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Historic Food Poisoning Prison Sentences Will Stand

Historic Food Poisoning Prison Sentences Will Stand

By Jennifer M. Thomas

Last month, the U.S. Court of Appeals for the Eleventh Circuit affirmed prison sentences for Stewart and Michael Parnell, and Mary Wilkerson, formerly of the Peanut Corporation of America (PCA). If you missed our earlier coverage of this historic case (here and here), PCA was responsible for a salmonella outbreak that killed at least nine people and sickened thousands in 2009.

In 2014, Stewart and Michael Parnell were convicted of fraudulently introducing misbranded (and, in Michael’s case, also adulterated) food into interstate commerce, interstate shipment and wire fraud, and conspiring to commit those crimes. Stewart and Mary Wilkerson were convicted of obstruction of justice. Stewart Parnell was sentenced to 28 years in prison followed by three years supervised release, Michael Parnell was sentenced to 20 years in prison followed by three years supervised release, and Mary Wilkerson was sentenced to 5 years in prison followed by two years supervised release. All three Defendants challenged their convictions and sentences on various grounds before the District Court for the Middle District of Georgia, and subsequently appealed to the Eleventh Circuit.

The Eleventh Circuit carefully dispensed the Defendants’/Appellants’ arguments, indicating that they raised no significant legal issues. The Court’s opinion that it stated at the outside that it “applied only established law” to the facts, and thus was “written only for the benefit of the parties.” Nevertheless, the Court went into particular detail about the Defendants’ collective claim that the jury’s verdict was tainted by extrinsic evidence of deaths caused by the salmonella outbreak (this evidence was excluded from the trial). Despite finding that individual jurors had, in fact, learned of the deaths during the trial and discussed those deaths during jury deliberations, the Court concluded, among other things, that (1) the District Court did not clearly err in refusing to credit the testimony of one juror who had expressed a bias towards Mary Wilkerson in the past, and (2) the weight of the evidence against the Defendants was such that the additional knowledge about the deaths did not influence or contribute to the verdict. Defendants’/Appellants’ other evidentiary and procedural arguments also failed.

While it is possible that the Parnells and Wilkerson will petition the U.S. Supreme Court for review, and/or petition the Eleventh Circuit for rehearing or hearing en banc, the chances that either court will grant such petitions are relatively slim. Therefore, this may well be the end of the line for Defendants– they will continue to serve out historic prison sentences. Despite the particularly egregious nature of the case, they may also serve as a cautionary tale.

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Proposed Legislation to Reform the OTC Drug Monograph System

Proposed Legislation to Reform the OTC Drug Monograph System

By Riëtte van Laack

On January 17, 2018, in an effort to overhaul the regulation of over-the-counter (OTC) monograph drugs, U.S. Senators Johnny Isakson and Bob Casey introduced bipartisan legislation, the Over-the-Counter Drug Safety, Innovation, and Reform Act, S.2315.

As readers of this blog know, the current monograph system, which was implemented in 1972, has received criticism and there have been several efforts to revise the system. Drawbacks include the slow rulemaking process (many OTC drugs are marketed under incomplete monographs), the inability to swiftly and promptly address safety issues, and barriers to innovation (eligibility is largely limited to active ingredients that were marketed before 1972).  In addition, FDA has asserted that it lacks the resources to effectively regulate the OTC monograph products.

The proposed bill is intended to speed up the slow time-consuming regulatory procedures by introducing the administrative order process to replace the current rulemaking procedures. It provides options for manufacturers to request administrative orders and for FDA to initiate administrative orders on its own initiative as well as in response to a citizens’ petition.

The bill would also establish a process for the introduction of new OTC products that are marketed without an approved New Drug Application. Under certain circumstances, such drugs would be subject to two-year exclusivity period.

The bill includes provisions that would provide FDA with the authority to take rapid action in event of safety issues with OTC drugs. It would also require that FDA evaluate the cold and cough monograph with respect to children under the age of six and report annually to Congress on the progress of this evaluation.

Importantly, the bill provides FDA with the authority to collect user fees to help cover much of the costs of the updated regulatory system and provide the necessary resources to evaluate and monitor the market.

Other than the two-year exclusivity provision, the proposed bill is similar to previous proposals. See, e.g., Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2017, authored by representatives Bob Latta (R-OR), Diana DeGette (D-CO), Chairman Burgess, Vice Chairman Brett Guthrie (R-KY), Ranking Member Gene Green (D-TX), and Rep. Debbie Dingell (D-MI).

We will be monitoring further developments.

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Guidance on Guidance

Guidance on Guidance

By Anne K. Walsh & Rachel E. Hunt

We have seen the stock language in every guidance document FDA issues claiming its guidance is non-binding:

This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

or

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.

This language provided little solace to FDA-regulated companies who have seen regulatory consequences result from a failure to comply with FDA’s guidance, for example in Warning Letters citing to guidance documents to support findings of noncompliance.

Until now. Last November, the Trump Administration reaffirmed that “the Administrative Procedure Act requires notice-and-comment rulemaking when purporting to create rights or obligations binding on members of the public or the agency,” and made clear its view that guidance “may not be used as a substitute for rulemaking.” The Department of Justice announced that it will discontinue its own practice of binding private parties without rulemaking, and imposed on itself the requirement that its guidance documents clearly state, among other things, “that compliance with those standards is voluntary and that noncompliance will not, in itself, result in any enforcement action.”

Last week, DOJ Associate Attorney General Rachel Brand announced that it will apply DOJ’s position about its own guidance documents to prohibit DOJ from using its civil enforcement authority to convert other agency guidance documents into binding rules. DOJ issued a memorandum directed at all DOJ civil litigators who bring affirmative civil enforcement (ACE) cases, defined as “civil lawsuits on behalf of the United States to recover government money lost to fraud or other misconduct or to impose penalties for violations of Federal health, safety, civil rights or environmental laws.” Of note, DOJ made clear that this policy is “new,” and that it “helps restore” the appropriate role of guidance documents. DOJ now limits the use of guidance documents to certain circumstances – e.g., to prove the requisite mens rea – and “effective immediately,” prevents civil litigators from using “noncompliance with guidance documents as a basis for proving violations of applicable law.” This policy applies to pending and future civil enforcement actions.

DOJ specifically identifies False Claims Act cases as subject to this new policy. For FDA-regulated companies, the impact could be huge. DOJ can no longer base False Claims Act cases on allegations that a company engaged in off-label promotion because it did not meet the requirements set forth in FDA’s Good Reprint Practice Guidance or the draft guidance governing Responses to Unsolicited Requests for Information.   It cannot support a theory that products are unapproved because they do not have the documentation recommended in FDA’s guidance on Deciding When to Submit a New 510(k) for a Change to an Existing Device or establishing Preamendment Status. And it cannot enforce requirements on compounding facilities that have failed to perfectly follow the countless guidance documents FDA has issued in lieu of notice-and-comment rulemaking.

We note that DOJ’s policy cannot stop FDA from continuing to allege violations of its guidance and taking administrative action against companies. Perhaps that will change soon. Nevertheless, the impact of the DOJ policy necessarily will extend to FDA enforcement decisions given DOJ involvement in any ACE cases brought to enforce FDA laws.

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Joint Action by FDA and FTC Against Companies Marketing Unapproved Opioid Cessation Products

Joint Action by FDA and FTC Against Companies Marketing Unapproved Opioid Cessation Products

By Riëtte van Laack

On January 24, 2018, FDA and the Federal Trade Commission (FTC) posted joint warning letters to 11 marketers and distributors of opioid cessation products, alleging that those products were unapproved new drugs that violated the Federal Food, Drug, and Cosmetic Act (FDC Act) and made unsubstantiated, deceptive claims in violation of the FTC Act.  Nine of the letters went to dietary supplement marketers, and two to marketers of homeopathic products. The FTC issued four additional warning letters to unidentified marketers of similar products, although it is not clear why those particular marketers (who apparently were not simultaneously targeted by FDA) were permitted to remain anonymous. While it is certainly not unprecedented for the FTC and FDA to issue joint warning letters, the large number of letters bespeaks the importance of this issue to both agencies.

At the end of 2017, an industry coalition of industry trade associations already reminded the industry and consumers that dietary supplement marketers cannot claim that their products treat opioid addiction or withdrawal symptoms.  Under the FDC Act, such claims cause the products to be unapproved drugs. Moreover, FDA has taken the position that opioid addiction is a condition that is not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner and, thus, opioid cessation products cannot be sold over-the-counter. They are regulated as prescription drugs.

As noted above, two of the warning letters, the letter to King Bio, Inc. and the letter to GUNA, Inc., target products labeled as “homeopathic” drugs. Many drug products labeled as homeopathic are manufactured and distributed without FDA approval under enforcement policies set out in the Agency’s Compliance Policy Guide (CPG), which FDA acknowledges in the letters. However, as FDA explains, this does not mean that any product meeting the CPG conditions can be marketed without approval, because “the enforcement policies set forth in the CPG are not unlimited.” Rather, the CPG “delineates those conditions under which homeopathic drugs may ordinarily be marketed in the U.S.” See FDA, Warning Letters to King Bio, Inc. and GUNA, Inc. (Jan. 11, 2018). There are special circumstances that supersede that policy, and the nationwide opioid crisis is one of those special circumstances.

As to the FTC Act violations, the letters note that the claims must be supported by competent and reliable scientific evidence at the time the claims are made. The FTC points to previous FTC enforcement actions challenging claims for the treatment of opiate addiction and withdrawal symptoms FTC v. Sunrise Nutraceuticals, LLC, and FTC v. Catlin Enterprises, Inc., as examples of the possible consequences of making unsupported claims.

FDA and the FTC have requested responses from all the companies within 15 working days.

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FDA Issues UDI Guidance for Class I and Unclassified Devices

FDA Issues UDI Guidance for Class I and Unclassified Devices

By Véronique Li * —

The final Unique Device Identifier (UDI) Rule was published on September 24, 2013. The last phases of implementation related primarily to Class I and Unclassified devices.  Due to complex issues identified during implementation of the UDI Rule for Class II and III devices, FDA is delaying compliance dates for implantation of the UDI Rule for Class I and Unclassified devices by two years.  Industry was notified of the Agency’s plan to delay last summer via letter, and this enforcement discretion policy has now been formally documented in FDA’s Immediately in Effect Guidance for Industry and FDA Staff, “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices,” issued on January 16.

The UDI Rule requires a device to have a UDI on its label and packages unless an exception or alternative applies. 21 C.F.R. § 801.20. There are special labeling requirements that apply to stand-alone software regulated as a device. 21 C.F.R. § 801.50). Additionally, the rule requires that certain dates on device labels be in a standard format.  FDA’s UDI system is designed to capture information regarding distributed and used devices and to incorporate this information in an integrated health system, including in the supply chain, registries, and electronic health records.

The UDI requirements have been phased in over the last five years beginning with highest-risk, Class III devices. The final two phases are set to occur on September 24, 2018 and September 24, 2020 with implementation of the below requirements:

Compliance Date Requirement
September 24, 2018 A class II device that is required to be labeled with a UDI must be permanently marked with a UDI on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
The labels and packages of class I and unclassified devices (i.e., those that have not been classified into class I, class II, or class III) must bear a UDI. § 801.20.
Dates on the labels of all devices, including devices that have been excepted from UDI labeling requirements, must be formatted as required by § 801.18.
Data for class I and unclassified devices that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.
Class I stand-alone software must provide its UDI as required by § 801.50(b).
September 24, 2020 Class I and unclassified devices that are required to be labeled with a UDI, must be permanently marked on the device itself with a UDI if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.

Since June 2014, 5% of guidances (8/152) issued by CDRH related to UDI topics. This number of guidances is remarkable given the time it takes to draft and review guidance documents, and the multitude of other important topics CDRH must address. Among these guidances was the November 2017 guidance relating to direct marking of devices with a UDI.  This guidance is noteworthy for those entities required to comply with the Class II marketing requirements taking affect in September 2018.

With the exception of the Class II direct marking requirements, last summer’s letter from FDA to industry extended all of the other upcoming compliance dates by two years. In this letter, FDA promised to issue guidance on articulating its enforcement discretion for the Class I and unclassified device compliance dates.  On January 16, FDA issued such guidance: the immediately-in-effect (for new acronym connoisseurs, IIE) document entitled, “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices.” The below table shows the original and new compliance dates based on the guidance.

Original Compliance Date Requirement New Compliance Date
September 24, 2018 Class II device direct marked with UDI September 24, 2018

(unchanged)

Labels and packages of class I and unclassified devices include UDI September 24, 2020
Dates on the labels of all devices to be formatted as required by § 801.18. September 24, 2020
Data for class I and unclassified devices submitted to GUDID September 24, 2020
Class I stand-alone software to provide its UDI September 24, 2020
September 24, 2020 Reusable and reprocessed class I and unclassified devices direct marked with a UDI September 24, 2022

According to the guidance, this extension was granted so that the Agency and industry could identify and address policy and technical challenges to ensure that UDI data are high quality, available, and integrated in standardized and meaningful ways from higher risk devices before focusing on lower risk devices.

In the guidance, FDA distinguishes between class I and unclassified devices manufactured and labeled on or after the original compliance date (September 24, 2018) and finished devices manufactured and labeled prior to the original compliance date established by the FDA. The latter group is excepted from the requirement to bear a UDI for a period of three years after that compliance date. In other words, if your device is manufactured before September 24, 2018, this inventory is afforded a three year exemption out to September 24, 2021. Practically speaking, this means that pre-September 24, 2018 inventory does not need to be reworked to include a UDI on its label or package until September 24, 2021.  If your device is manufactured between September 24, 2018 and September 24, 2020, you lose this rework grace period and are expected to comply with UDI requirements as of the new compliance date (September 24, 2020).  This might prove to be complicated logistically; companies will need to rework inventory built between September 24, 2018 and September 24, 2020 before the new compliance date while not needing to rework pre-September 24, 2018.  FDA offers no rationale for the use of different, misaligned compliance dates.

While this guidance is intended to reduce the burden associated with the UDI rule for finished devices, it appears that misalignment between enforcement dates for devices manufactured before September 24, 2018 and between September 24, 2018 and September 24, 2020 could actually create more burden and confusion. We recommend interested parties comment on the burden that this misalignment will create in two and a half years when the requirements will take effect.

* Senior Medical Device Regulation Expert

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Now Hear This: FDA Issues Draft Guidance on Public Warning and Notification of Recalls

Now Hear This: FDA Issues Draft Guidance on Public Warning and Notification of Recalls

By Ricardo Carvajal

FDA issued a draft guidance that addresses public warning and notification of recalls under the agency’s recall regulation at 21 CFR part 7, subpart C (see here and here).  Although the draft guidance extends to recalls of nearly all FDA-regulated products, it is of particular importance to the food sector because it follows on the heels of an HHS OIG report critical about the agency’s oversight of certain food recalls.  In response to that report, Commissioner Gottlieb issued a statement indicating that the agency intended to take “additional policy steps… as part of a broader action plan to improve our oversight of food safety and how we implement the recall process.”  The issuance of the draft guidance appears to be the first of those additional policy steps.

The draft guidance addresses both public warnings (meaning an alert to the public that a recalled product presents a serious health hazard), and public notification (meaning inclusion in the agency’s publicly available weekly Enforcement Report, which lists all recalls regardless of the level of hazard).   The draft guidance discusses the circumstances under which firms should issue public warnings, examples of serious hazards that could warrant a public warning, and the preparation, content, and distribution of such warnings.  The draft guidance notes that the agency could choose to issue its own public warning, and also can “publicly issue information that may address outstanding questions about the nature of the incident and/or the agency’s action.”  A footnote acknowledges that certain information might qualify as confidential commercial information (CCI) and thereby be generally exempt from public disclosure, but points to an FDA regulation that authorizes disclosure “to the extent necessary to effectuate” an “administrative or court enforcement action within [the agency’s] jurisdiction.”

With respect to public notification, the draft guidance states that recalls will be posted in the weekly Enforcement Report only after FDA has determined that the action qualifies as a recall, as defined by the recall regulation.  At that point, the recall will be posted even if it has yet to be classified.

Comments on the draft guidance are due by March 20, 2018.

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Nothing Appealing in Proposed Device Appeal Regulations: They are Identical to Existing Guidance

Nothing Appealing in Proposed Device Appeal Regulations: They are Identical to Existing Guidance

By Allyson B. Mullen

The title of this blog post should tell you everything you need to know about the proposed appeal regulations announced last week by CDRH (found here). On January 17, CDRH proposed regulations specific to the device appeal process for both 517A decisions as well as non-517A decisions.  The notice announcing the proposed regulations states that they are intended to “provide transparency and clarity for internal and external stakeholders” on the device appeal process.  However, in our view, the proposed regulations add nothing to the existing guidance available to industry and the Agency regarding the device appeal process.

By way of background, as we have previously posted on (here, here, and here), the device appeal process was significantly modified in the Food and Drug Administration Safety and Innovation Act (FDASIA), which created Section 517A of the Federal Food, Drug, and Cosmetic Act (FDC Act). Section 517A defined certain decisions by CDRH (e.g., 510(k) NSE, PMA denial and not-approvable decisions) that were subject to specific timeframes (i.e., appeal must be received by CDRH within 30 days from the decision and date) and bound CDRH to responding to such appeals:

  • within 45 days from receipt if an appeal meeting is not requested; or
  • within 30 days from an appeal meeting, if requested, and such meeting must be held within 30 days of receipt of the appeal letter.

The Agency has subsequently issued guidance on this topic: “Center for Devices and Radiological Health Appeals Processes” (Appeal Guidance) and “Questions and Answers About 517A” (Q&A Guidance).

The 21st Century Cures Act (Cures Act) expanded the list of Agency decisions subject to Section 517A procedures by adding decisions on breakthrough designation requests.  In September 2017, CDRH revised its Q&A Guidance to include such decisions on the list of 517A decisions, resulting in the following list of decisions subject to the 517A requirements:

  • 510(k): Not Substantially Equivalent; Substantially Equivalent
  • PMA/HDE: Not Approvable; Approvable; Approval; Denial
  • Breakthrough Devices: Granting; Denial
  • IDE: Disapproval; Approval
  • Failure to Reach Agreement on a Protocol under Section 520(g)(7) of the FD&C Act
  • “Clinical Hold” Determinations under Section 520(g)(8) of the FD&C Act

The guidance includes the following illustrative list of non-517A decisions:

  • 510(k) Requests for Additional Information
  • PMA Major Deficiency Letter
  • 510(k) and PMA Refuse to Accept Letters
  • Postmarket Surveillance Orders under Section 522 of the FD&C Act
  • CLIA Waiver Decisions
  • Warning Letters
  • Response Letter to a Request for Information under Section 513(g) of the FD&C Act

The non-517A decisions are not subject to the 517A timeframes, but according to the Appeal Guidance, in order to be timely an appeal of a non-517A decision should be received by FDA within 60 days of the decision date. The Appeal Guidance set no timeframes for CDRH’s review of non-517A appeals meaning that they could potentially languish for extended periods of time – the issue that led to creation of 517A in the first place.

These lists obviously do not cover all FDA decisions. Most notably, de novo submissions are not included.  Since FDASIA and the Cures Act (the statutes establishing and revising the device appeal process), de novo submissions have become subject to significant user fees (in excess of $90,000).  When CDRH announced its proposed regulations addressing appeals, we hoped FDA would include de novo submissions in the list of 517A decisions, although not required by statute.  Certainly given the new price tag, applicants should have the certainty associated with the appeal process for other significant premarket submissions.  And, given the increased popularity of de novo applications, more companies are interested in that certainty.

The proposed regulations also do not include any Agency procedures (e.g., timing) for review of non-517A decisions. The notice announcing the proposed regulations does, however, discuss at length the naming of non-517A decisions.  Section 517A of the FDC Act pertains to “significant decisions.”  In its earlier guidance, FDA used this same terminology referring to 517A decisions as “significant decisions.”  FDA stated that it did not want to refer to non-517A decisions as “insignificant decisions” (as may be implied by referring to 517A decisions as “significant”) because they are still important even though not expressly identified in Section 517A.  Regardless, however, of what the regulations call these decisions, the lack of Agency procedures for their review highlights their insignificance when it comes to the appeal process and leaves appeals of these decisions at a significant disadvantage as compared to 517A decisions.

Much to our disappointment, the proposed regulations did not address either of these major issues. As indicated at the outset, the proposed regulations simply regurgitate the statutory timeframes and submission types for 517A decisions.  With regard to non-517A decisions, the proposed regulations simply state that appeals must be filed by the applicant within 60 days of the decision.  There are no requirements for the Agency with regard to reviewing or responding to such appeals.  We find the lack of additional clarity and procedures in the proposed guidance somewhat astonishing given that industry and the Agency already understood these procedures and timeframes based on existing guidance.  FDA is accepting comments on the proposed regulations through April 17, 2018.  We strongly recommend those interested in the appeals process comment.  These seemingly arcane procedural elements can help determine the outcome of a submission.

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