Attorney East Hampton

Although the Drug Supply Chain Security Act of 2013 (DSCSA) required publication by 2015 of guidance addressing grandfathering of certain product identifier requirements for packages or homogeneous cases of finished dosage form prescription drugs, “its better late than never,” as the saying goes.  On Monday November 27th, FDA announced the availability of draft guidance titled, “Grandfathering Policy for Packages and Homogenous [SIC] Cases of Product Without a Product Identifier.” Comments on the proposed draft are due by January 26, 2018. As FDA states in its Federal Register Notice announcing the draft guidance, a critical part of the DSCSA (Section 582(a)(5)(A)) requires each package and homogeneous case of product in the supply chain to contain by a specific date a product identifier encoded with the product’s standard numerical identifier, lot number, and expiration date.  FDA’s draft guidance specifies whether and under what circumstances packages and homogeneous cases of product not labeled with an identifier will be exempt (“grandfathered”) from Section 582’s identifier requirement.

FDA states that this draft guidance must be read in conjunction with FDA’s previously issued draft guidance titled, “Product Identifier Requirements Under the Drug Supply Chain Security Act” (see our previous post here) where FDA announced, among other things, that it will exercise enforcement discretion for manufacturers that do not add a product identifier to each package and homogeneous case of product intended to be introduced in a transaction into commerce before November 27, 2018 (i.e., delaying the serialization deadline by one year).

The “scope” of the latest draft guidance is as follows: A package or homogeneous case of product “is in the ‘pharmaceutical distribution supply chain’ if it was packaged by the product’s manufacturer before November 27, 2018.”  (Emphasis added.)  Thus, a package or homogeneous case of a product that is not labeled with a product identifier “is eligible for an exemption under Section 582(a)(5)(A)” as described in the guidance ”only if the product’s manufacturer packaged the product before November 27, 2018.” (Emphasis added.)  There also must be documentation that the product was packaged by a manufacturer before November 27, 2018.  As an example, FDA states that if a package or homogeneous case not labeled with a product identifier is accompanied by transaction information (TI) or a transaction history (TH) indicating a sale before November 27, 2018, then a trading partner may “reasonably conclude” the product was “packaged” by the manufacturer before that date.  However, if TI or TH does not include a sale prior to November 27, 2018, absent other indications that the product may be suspect or illegitimate, then the transaction statement (TS) “is one indication that the product was in the pharmaceutical distribution supply chain before that date.”  One could wonder here whether “packaged” but “unsold” products qualify for the grandfathering exemption, and whether this will cause confusion for industry.

Concerning trading partner requirements under the grandfathering exemption, the draft guidance notes as follows:

Manufacturers, distributors, and dispensers are exempt from two requirements in Section 582 where there is documentation showing that the unserialized product was in the pharmaceutical distribution supply chain before November 27, 2018:

For Manufacturers:

• Where investigating an unserialized product to determine whether it is illegitimate, the manufacturer is exempt from the requirement to use the product identifier for verification. However it still must validate the TH and TI, and otherwise investigate pursuant to Section 582(b)(4)(A)(i)(H).
• In circumstances were the authorized trading partner in possession of the product requests verification from the manufacturer, the manufacturer is exempt from verification using the product identifier, but still must follow the other requirements in Section 582(b)(4)(C) (i.e., advise concerning whether the product is indeed suspect or illegitimate).

For Wholesale Distributors:

• Wholesale distributors are exempt from Section 582(c)(2), which requires they only engage transactions involving serialized product after November 27, 2019.
• Wholesale distributors shall not be required to verify product using the product identifier beginning November 27, 2019, but they must validate applicable TH, TI and TS in their possession to determine whether the product is illegitimate.

For Dispensers:

• Dispensers are exempt from Section 582(d)(2), which requires they only engage transactions involving serialized product after November 27, 2020.
• Wholesale distributors shall not be required to verify product using the product identifier beginning November 27, 2020, but they must validate applicable TH, TI and TS in their possession to determine whether the product is illegitimate.

For Repackagers:

The grandfathering exemption applies to repackagers, with certain limitations:

• Repackagers are partially exempt when they receive unserialized product after November 27, 2018, if they accept product without a product identifier after that date. However, if the repackager transfers ownership of a product without an identifier after November 27, 2018, it must add a product identifier to the package or homogeneous case.
• Like other trading partners mentioned above, repackagers will not be required to verify a product using the product identifier (if the product does not have one) after November 27, 2018, but it must take other steps outlined in the statute to otherwise investigate whether the product is illegitimate, including verifying TH and TI in its possession.
• If a repackager initially repackaged and sold unserialized product prior to November 27, 2018, it is exempted from the requirement that, upon request, it verify the product using the product identifier, but it must still follow other relevant statutory requirements.

Importantly, the draft guidance states that trading partners may engage in transactions involving grandfathered products until product expiry. FDA states that, although there is no “sunset” date for the grandfathering exemption, it expects few unserialized products  to remain  in the supply chain by November 27, 2023.

Lastly, concerning saleable returned packages and homogeneous cases of product (i.e., trading partners’ accepting returns of and redistribution of product), for returns without product identifiers after November 27, 2018, manufacturers, distributors and repackagers are exempt from the requirement to verify the product identifier.  Manufacturers are exempted from the requirement to add an identifier before redistribution.  Repackagers are exempted from the requirement so long as they initially repackaged and sold the product without an identifier before November 27, 2018.

FDA makes clear that unlike the guidance on Product Identifier Requirements, above, where FDA is exercising enforcement discretion, in this draft guidance, eligible product is “grandfathered” or exempted from certain statutory requirements.

The recently-enacted Food and Drug Administration Reauthorization Act (“FDARA”) includes the Medical Device User Fee Amendments of 2017 (“MDUFA IV”) (see our summary here).  This new law affects multiple aspects of the device review process.  MDUFA IV supplements FDA’s funding of device regulation, with the goal of increasing the speed and efficiency of the Agency’s review of new devices, as well as improving the safety and effectiveness of marketed devices.  In addition to modifying the user fees, MDUFA IV broadens the scope of submission subject to user fees and performance goals.

Hyman, Phelps & McNamara, P.C.’s Jeffrey N. Gibbs will be moderating the Food and Drug Law Institute’s (“FDLI’s”) November 30, 2017 webinar, titled “MDUFA IV and Related CDRH Guidance Documents: Impacts on Industry.”  Webinar panelists will discuss relevant aspects of FDARA and the MDUFA IV Commitment Letter, highlight major changes to the program, and discuss the effects on the device industry, including the issuance of substantive key new guidance documents, such as when new 510(k)s must be submitted.

Additional information on the FDLI webinar, including registration information, is available on FDLI’s website here.

Last week FDA formally announced yet another transparency initiative – this time, it’s the inclusion of patent submission dates in the Orange Book!  (FDA informally announced the change a couple of weeks ago with a note in the Orange Book stating: “Effective November 21, 2017, the Orange Book search results and drug listings will display patent submission dates where available.”) In accordance with FDA’s October 2016 final rule implementing portions of the 2003 Medicare Modernization Act (“MMA”), FDA has decided to publish this information in the Orange Book prospectively.  (That being said, FDA began patent submission date data collection in 2013, and the newly updated Orange Book includes patent submission dates since then.) According to FDA’s press release announcing the change, the data are intended to “help generic manufacturers determine the earliest date when they may be able to market new generic medicines.”

This is a big – and important – change to the Orange Book.  Now applicants will have a much clearer picture on timely listed patents and whether listed patents indeed require certification. Knowing the submission date will also help clarify whether a listed patent will trigger a 30-month patent litigation stay, otherwise delay approval of a pending application, or require a carve-out.

Previously, patent submission date information was available only by contacting the Orange Book Staff.  This made it difficult for generic companies to determine if a patent was late-listed, relisted, or properly listed, and therefore difficult to know whether an ANDA applicant needed to include a patent certification or needed to update an application with an amended certification.  All this information should be a lot clearer with this development.  Hopefully, this will streamline the process for generic drug manufacturers and cut down on some work for the Orange Book Staff.

Like any other corrections to the Orange Book, NDA holders should contact the Orange Book staff with any correction requests (with justification).

As noted, this new information is only published on a prospective basis, and going back to 2013 when FDA began collecting patent submission date information.  That means there are about 4,000 patent records for which submission dates are available and that are now published in the Orange Book. For the remaining thousands of patents without a published patent record, interested parties will still have to reach out to FDA for patent submission information.

The Association for Accessible Medicines (“AAM”) recently submitted extensive comments to FDA in response to the Agency’s June 2017 Federal Register Notice on “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access.” Among AAM’s litany of suggested changes and improvements is a request that FDA update the Orange Book with more comprehensive patent information:

Knowing whether patent information is timely submitted to FDA for Orange Book listing is information critical to ANDA applicants. For example, a company with a pending ANDA is not required to certify to new patent information listed in the Orange Book if such patent information is listed more than 30 days after patent issuance, or more than 30 days after a relevant approval under an NDA making a previously issued patent listable.

FDA should amend the Orange Book to include a new column in the “Patent and Exclusivity List” that identifies the date on which a particular patent was considered listed in the Orange Book. Supplying such information in a readily accessible document would avoid companies and their representatives having to send multiple requests to FDA to supply such information, and should immediately clarify for ANDA applicants whether a patent is timely listed and must be addressed in a patent certification.

With FDA’s recent announcement on Orange Book patent submission date information, that’s one item FDA and AAM can check off the list of improvements.

On October 30, CDRH finalized the guidance entitled, “Manufacturers Sharing Patient-Specific Information From Medical Devices With Patients Upon Request”.  This is the final version of the guidance, “Dissemination of Patient-Specific Information from Devices by Device Manufacturers” issued in June 2016 (see our blog post on the draft here.)

We do not typically comment on guidance name changes from draft to final, but in this case the addition of “Upon Request” to the final guidance name marks a significant change from the draft to final guidance. The draft guidance contemplated prospective, unrequested dissemination of patient-specific information from medical devices.  The final guidance, however, is limited to providing such information in response to a “request.”  The guidance does not explain or define a request other than to say that a request could be directed to a patient’s healthcare provider or a device manufacturer.

The draft guidance was significant precisely because it allowed device manufacturers to share patient-specific data, including interpretive information, directly with patients without the communication being considered labeling or requiring a new premarket clearance or approval. The more limited scope of the guidance certainly tempers the importance of the guidance if providing data upon request will have a much more limited impact.  The guidance highlights that patients are taking greater interest in and control of their health.  However, patients are likely to request certain information only if they know of its availability.  The guidance is silent as to whether a patient’s request can be solicited or not.  For example, would this guidance still apply if a manufacturer posts on its website that certain information from its device can be shared upon request?  Without specific restriction in the guidance, it appears the answer would be yes, unless FDA viewed this as improperly soliciting an unsolicited request.

In the draft guidance, the flow of information was from a device manufacturer to a patient directly. The guidance indicates that often times patient-specific information is accompanied by other explanatory text.  If a healthcare provider could also be disseminating patient-specific information, it may be appropriate for device manufacturers to have a standard template for such communication.  However, the guidance is silent on this point.

The definition of “patient-specific information” is relatively unchanged from the draft to final guidance. However, notably the final definition excludes the statement that the device information be “consistent with the intended use of the medical device.”  The final guidance defines patient-specific information as:

information unique to an individual patient or unique to that patient’s treatment or diagnosis that has been recorded, stored, processed, retrieved, and/or derived from a legally marketed medical device. This information may include, but is not limited to, recorded patient data, device usage/output statistics, healthcare provider inputs, incidence of alarms, and/or records of device malfunctions or failures.

Like the draft guidance, the final states that interpretive information should be limited to “interpretations of data normally reported by the device to the patient or the patient’s healthcare provider.” To illustrate this point, the final guidance provides the following example as falling outside the scope of this guidance:  “results of individual component tests for specific analytes that comprise or are utilized in a cleared assay but have not been individually approved or cleared to test for those specific analytes.”  Thus, even though the “consistent with the intended use of the medical device” has been removed from the final definition, the remainder of the information continues to suggest that any patient-specific information provided should still be consistent with the intended use.

The final guidance, like the draft, emphasizes the need for providing comprehensive and contemporaneous information to patients, and manufacturers sharing such information should consider the content and context of the dissemination when responding to requests. The final guidance, interestingly, provides less guidance on these points than the draft.  We expect that manufacturers seeking to provide patient-specific information will still have a lot of questions that are unanswered by this guidance before they start sharing information.

The Food and Drug Law Institute’s (“FDLI”) Enforcement, Litigation, and Compliance Conference is just a few weeks away, and spaces are going fast!  The two-day conference will be held on December 6-7, 2017, in Washington, D.C.  Hear from new government officials, including Rebecca Wood, the new Chief Counsel for FDA, and Ethan Davis, the newly appointed Deputy Assistant Attorney General, Consumer Protection Branch, US Department of Justice.

Attendees will:

• Explore the latest enforcement action trends in food, drugs, biologics, medical devices, and tobacco
• Gain practical tips and best practices for responding to enforcement action by FDA or other government agencies
• Learn how to comply with new and upcoming FDA rules and regulations
• Hear from FDA’s Center Compliance Directors on priorities for 2018 and from ORA on the status of Program Alignment.

Hyman, Phelps & McNamara, P.C.’s Anne K. Walsh will present on enforcement issues throughout the supply chain.  View the full agenda at here and register using the discount code, save10.

The American Conference Institute’s Legal, Regulatory, & Compliance Forum on Controlled Substances is scheduled to take place in Washington, D.C. from January 29-31, 2018.

Esteemed, top-notch faculty speaking at the conference include current and former officials from the DEA and FDA, representatives from State Attorney General and U.S. Attorney Offices, as well as high-level in-house executives, and top outside counsel. Conference speakers will provide their insights into the most pressing topics affecting the space such as:

• Reassessing your Responsibilities in Light of the Changing Scope of Suspicious Order Monitoring Requirements
• Evolution of Abuse-Deterrent Opioid Drug Products
• Understanding and Comparing State Prescription Drug Monitoring Programs
• Diving into the State, County, and City Opioid-Related Investigations

Hyman, Phelps & McNamara, P.C.’s John A. Gilbert, Jr. will be speaking at a session titled “Overcoming Challenges for Schedule III Opioids and Non-Opioid Products,” and will be moderating a panel discussion, titled “Politics and Policy of Controlled Substances in View of the Opioid Overdose Crisis.”

FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. The discount code is: P10-999-FDAB18. You can access the conference brochure and sign up for the event here. We look forward to seeing you at the conference.

The American Conference Institute’s Legal, Regulatory, & Compliance Forum on Controlled Substances is scheduled to take place in Washington, D.C. from January 29-31, 2018.

Esteemed, top-notch faculty speaking at the conference include current and former officials from the DEA and FDA, representatives from State Attorney General and U.S. Attorney Offices, as well as high-level in-house executives, and top outside counsel. Conference speakers will provide their insights into the most pressing topics affecting the space such as:

• Reassessing your Responsibilities in Light of the Changing Scope of Suspicious Order Monitoring Requirements
• Evolution of Abuse-Deterrent Opioid Drug Products
• Understanding and Comparing State Prescription Drug Monitoring Programs
• Diving into the State, County, and City Opioid-Related Investigations

Hyman, Phelps & McNamara, P.C.’s John A. Gilbert, Jr. will be speaking at a session titled “Overcoming Challenges for Schedule III Opioids and Non-Opioid Products,” and will be moderating a panel discussion, titled “Politics and Policy of Controlled Substances in View of the Opioid Overdose Crisis.”

FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. The discount code is: P10-999-FDAB18. You can access the conference brochure and sign up for the event here. We look forward to seeing you at the conference.

On November 14, 2017, the USDA Agricultural Marketing Service (AMS) announced that it will further delay and reconsider the Organic Livestock and Poultry Practices (OLPP) regulations.  This is not the first delay of the effective date for the OLPP regulations.

The OLPP final rule amends the organic livestock and poultry production requirements of the organic regulations by adding provisions for (1) livestock handling and transport for slaughter; (2) avian living conditions; and (3) expanding and clarifying existing requirements covering livestock care and production practices and mammalian living conditions. The final rule was issued on January 19, 2017, in the last 24 hours of the Obama administration. The effective date for the rule was March 20, 2017.  However, in March, consistent with the memorandum “Regulatory Freeze Pending Review,” AMS delayed the effective date by 60 days.

Next, on May 10, 2017, nine days before the new effective date, AMS announced a further delay of the effective date; this time by six months, until November 14, 2017, because “significant policy and legal issues addressed within the final rule warranted further review by USDA.”  Concurrently, AMS issued a proposed rule requesting comments on the course of action for the final rule.. AMS asked comments on four possible options:

1. Let the rule become effective on November 14, 2017.
2. Suspend the rule indefinitely to allow time to consider whether to implement, modify or withdraw the final rule.
3. Delay the effective date of the rule further, beyond the effective date of November 14, 2017.
4. Withdraw the rule.

AMS received more than 47,000 comments. More than 40,000 comments (34,600 of which apparently were submitted as form letters) selected “Option 1: Implement,” 28 comments supported “Option 4: Withdraw,” some comments supported “Option 2: Suspend”; and only one comment selected “Option 3: Delay.” In light of these results, the announcement of another six months delay is somewhat surprising.

So why did AMS decide to delay the effective date yet again? According to the announcement in the Federal Register, AMS has concluded that “important questions regarding [its] statutory authority to promulgate the OLPP rule and the likely costs and benefits of [the] rule” need to be more fully assessed. AMS now questions whether it has the authority, under the Organic Food Production Act (OFPA), to issue regulations “reflecting a stand-alone concern for animal welfare.” It asserts that it has concluded that “OFPA’s reference to additional regulatory standards ‘for the care’ of organically produced livestock is limited to health care practices.” In addition, AMS is uncertain that the OLPP is consistent “with USDA regulatory policy principles . . . . because the requirements in [the] rule may not represent the most innovative and least burdensome tools for achieving regulatory ends.” AMS also is concerned that due to an error in the calculation of the benefits, it may have overestimated the benefits of the final rule. In light of these questions and uncertainties, AMS does not want to proceed with the implementation of the rule. Instead, a delay to allow for careful reconsideration is warranted.

Presumably, AMS will issue a proposed rule for comments on the revised cost benefit analysis and AMS’s interpretation of its (limited) authority under the OFPA in the near future.

Meanwhile, a September 2017 lawsuit by the Organic Trade Association challenging AMS’s repeated delays of the effective date as violations of the Administrative Procedures Act and the OFPA remains pending. As a result of the delay of the effective date, that proceeding also is delayed.

If you happened to log on to the FDA Law Blog or the Hyman, Phelps & McNamara, P.C. (“HPM”) websites over this past weekend, then you probably noticed some big changes. We’ve totally overhauled and upgraded the blog and the HPM websites to bring them into modern times and to better reflect our FDA expertise and the creative personality of HPM.  In fact, our new firm tagline is “Expertise in all things FDA.”

As for the FDA Law Blog, after celebrating 10 years of blogging earlier this year (see our previous post here), and during which 10 years we didn’t really invest much time and resources into making things “pretty,” we thought it was time to change things up. 

Continue reading Introducing FDA Law Blog 2.0! at FDA Law Blog.

Small business owners and managers of chain restaurants subject to FDA’s menu labeling rule remain confused as to the criminality of adding an extra dollop of ketchup to a hamburger. One thing is now clear — the only way to stop FDA’s years of wasteful dithering on menu labeling is for Congress to intervene.

Last week, FDA issued another in a string of guidance documents, and again failed to explain or simplify the hopelessly complex regulations aimed at requiring the disclosure of calories on menus in chain restaurants.

Continue reading An Extra Dollop of Ketchup is Not a Crime! Or is it? Confusion Over Calories on Menus Continues at FDA Law Blog.