Attorney East Hampton

Not guilty. For anyone having been charged with a crime, the whole world hinges on those two words. In a jury trial, those two small words are the ones you pray are read by the jury foreperson at the end of deliberations. Many factors determine the outcome of the proceedings, but none is more important than your defense.

Once you have researched and selected your Sugar Land criminal lawyer to defend you, it is imperative to work together on your strategy. Depending upon the crime you have been accused of, you need to be prepared in case yours goes to trial. There are several standard criminal defenses you could conceivably use, contingent upon the crime you’ve been accused of committing and depending upon what is appropriate to the circumstances of the case.

One such strategy is the Affirmative Defense, where the defendant admits the crime but has a viable explanation for their actions. For instance, a person may admit to killing another person, but maybe in the heat of the moment, not as a premeditated act. This could get the charges dropped down to a lesser offense. There are several different Affirmative Defenses, including entrapment, coercion, necessity, insanity or self-defense.

Entrapment means that yes, you committed the crime, but you would not have done so unless you had been enticed by a police officer or another law enforcement agent. The burden of proof is showing that you would not have otherwise committed the crime had the officer not somehow coaxed you into doing so.

In a similar vein, coercion can be an affirmative defense if you can prove that someone had threatened you into submission so that you felt you had no choice but to commit the crime.

Another affirmative defense is a necessity, meaning that committing the crime was a necessity to avoid greater harm. To use this defense, you would have to prove that there were no other alternatives other than committing the crime and that you stopped the action as soon as the danger passed. You would also show you were not responsible for the danger that needed to be avoided. Essentially, this is a “lesser of two evils” type of defense.

The insanity defense is one of TV folklore but also a viable defense, though very difficult to use successfully. You would have to show clear evidence that you were suffering from a mental defect at the time of the crime and that it made you unable to determine that your actions were wrong.  There will be extensive psychological examinations by both the defense and the prosecution’s experts to ascertain your mental state now and at the time of the transgression. While you may not be convicted of the crime and you may not serve jail time, instead you may be sent to a mental facility for extended care.

You could also claim self-defense or defense of another person as a tactical approach to your case. You would admit your culpability to the crime but you would present evidence that you were protecting yourself or someone else from harm. For this defense to be feasible, there would have to have been a threat to your life, or the life of someone else and there was no other possible recourse than the action you took. If someone carjacks you at gunpoint and threatens to shoot you if you don’t turn over the vehicle and you instead shoot the perpetrator, you could claim self-defense.

There are other possible defenses including consent, where you acknowledge you committed the crime, but you assert that the victim consented to the action. You could also claim intoxication, but of course that doesn’t negate your responsibility for your actions, but it could be used to show that you should receive a lighter penalty. Also important is the statute of limitations involved. If the prosecution takes too long to file charges, you can have the charges dropped if it exceeds the statute of limitations. For example, if you robbed a bank, the federal statute of limitations is five years. After that point, you cannot be federally charged for bank robbery, although state laws vary. Discussing all the defense options, the evidence at your disposal, and the particulars of your unique case are the fundamentals of your relationship with your attorney.

There are also some unconventional defenses that have actually had their day in court, sometimes with surprising results. Back in the 1980s, a case went to trial where the defendant claimed he drove fourteen miles, stabbed his mother-in-law to death, and then headed directly to the police station. He claimed he had no memory of any of the events and his criminal defense attorney proposed that he had committed the crimes while sleepwalking. Since there was no one to corroborate his claim, the defendant was subjected to an EEG scan of his brain and it was determined that he had abnormal brain activity associated with a sleep disorder. The results of the EEG coupled with the defendant’s testimony and his lack of motive for the crime were enough for the jury to find him not guilty.

Then there is the so-called “Twinkie Defense”. Although it was never an actual courtroom defense, its reputation lingers on. Dan White, a San Francisco supervisor held a vendetta against the Mayor and a gay Supervisor and he shot them both to death. White was portrayed as a clean-cut, conservative person who suffered from bipolar disorder and had increasing displeasure with the liberal stance of the Mayor and the gay supervisor, leading him to “snap” and commit these murders. The “Twinkie Defense” was an expansion on White’s bipolar condition; that ingesting junk foods could have affected his mood, to the tipping point of murder. Although it was proven that White purposefully snuck a gun into City Hall by avoiding the metal detectors, then shot the Mayor twice, reloaded the gun, and shot the supervisor, White’s punishment was voluntary manslaughter and he served just a few short years for his crimes. Although Twinkies had nothing to do with his verdict, the press grasped onto one element of the testimony—that White was so depressed that he consumed nothing but junk food in the days before the murders and that led him to ultimate actions. Hence, the “I got all jacked up on sugar from Twinkies and killed two people” became a notion in the public accepted, even though it was not White’s actual defense.

Finding the right fort bend criminal defense attorney for your case is probably the most important piece of your defense. Having someone who is a savvy, smart, experienced lawyer, and articulate may be the difference between a Twinkie verdict or a life sentence, so make your choice wisely.

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By Anne K. Walsh —

In a memo issued by the Attorney General to all civil litigators throughout the country, AG Sessions set forth the DOJ position that it would seek to limit courts from applying “overbroad injunctive relief” in cases involving “nationwide injunctions.”  A “nationwide injunction” is one in which the federal government is barred from enforcing a law or policy as to any person or organization regardless of whether the person is a party to the litigation challenging the law or policy.  In the FDA context, a plaintiff can bring an Administrative Procedure Act (APA) challenge to a particular FDA regulation, and the court, in deciding in favor of the plaintiff, may vacate the challenged rule so that it does not apply to any person.  (See, for example, the Washington Legal Foundation challenge to FDA’s enforcement policy against off-label communications and seeking to enjoin FDA from taking further enforcement action.)

DOJ’s position set forth in the memo is that a court cannot act outside the bounds of its authority by granting relief beyond the particular case or controversy. Although the memo asserts that this position has been longstanding under “Administrations of both parties,” the DOJ memo instructs its litigators to make the following arguments, as appropriate, to defend against the issuance of a potential nationwide injunction:

1. Nationwide injunctions are inconsistent with constitutional limitations on judicial power – The memo focuses on the equitable power of Article III courts and modern standing doctrine;
2. Nationwide injunctions have no basis in equitable practice – The memo calls this type of relief an “ahistorical anomaly.”
3. Nationwide injunctions impede the consideration of a disputed legal issue by different courts – The memo seems to welcome the “organic development and discussion” by lower courts of a contested legal issue, without reference to the policy of conserving judicial resources.
4. Nationwide injunctions undermine legal rules intended to ensure the orderly resolution of disputed legal issues – The memo argues that the class action system is sufficient to provide relief to large numbers of similarly situated people and that the federal government is entitled to relitigate matters in multiple circuits, citing the principle of nonmutual offensive collateral estoppel as not applying to the federal government.
5. Nationwide injunctions interfere with judgments that properly belong to other branches of government – The memo claims that Congress must first establish by statute when a single court has authority to review agency actions with nationwide applicability, and that the Executive Branch (and in the particular the discretion of the Executive) decides whether to abide by an adverse ruling outside the geographical region in which the ruling is binding.
6. The availability of nationwide injunctions undermines public confidence in the judiciary – The memo points to forum shopping as an institutional danger to the judiciary.

The memo devotes an entire section presenting arguments to be made in APA challenges. The APA states that a reviewing court can “hold unlawful and set aside agency action, findings and conclusions” that are arbitrary and capricious, contrary to constitutional rights, in excess of statutory jurisdiction, without observance of procedure, unsupported by substantial evidence, or unwarranted by the facts.  5 U.S.C. 706.  The DOJ memo argues that this statutory language does not expand the limitation on a court to grant relief only to the parties before it.  Specifically, DOJ lawyers are instructed to make the following arguments in APA cases:

1. The relevant “agency action” is the application of the regulation to the plaintiff, not the regulation itself, so the court should not go beyond the boundaries of the case to invalidate the regulation.
2. Even if the regulation is the subject of the challenge, the APA does not require that the rule, if found invalid, be set aside on its face or as applied to the challenger.
3. The APA provides for declaratory and injunctive relief in the absence of a special statutory review provision, and this type of relief is traditionally limited to the parties involved in the litigation.

This APA section reads like an excerpt to be dropped directly into a legal brief, and it will be interesting whether courts ultimately will agree with these legal arguments when presented by DOJ lawyers.

By David B. Clissold & Gugan Kaur —

A few months ago we reported on FDA’s recent enforcement efforts targeting electronic nicotine delivery systems (ENDS), such as e-cigarettes, and warned that the Agency is watching retailers and manufacturers closely (see here and here).

In a September 12, 2018 announcement, FDA summarized its enforcement efforts to reduce underage access to e-cigarettes over the last few months. Calling it “the largest coordinated enforcement effort in the FDA’s history,” the Agency reported that between June and September 2018, more than 1,300 Warning Letters and civil money penalty complaints were issued to e-cigarette retailers and manufacturers for illegally selling e-cigarette products to minors.  The violations were discovered during an “undercover blitz of brick-and-mortar and online stores” conducted by FDA.

In a direct challenge to industry, FDA Commissioner Gottlieb said that there were “clear signs that youth use of electronic cigarettes has reached an epidemic proportion, and we must adjust certain aspects of our comprehensive strategy to stem this clear and present danger.” Dr. Gottlieb stated that, although FDA had exercised discretion for e-cigarette products as part of the attempt to develop a pathway to transition adult smokers off combustible cigarettes, in light of the increased use by minors, the Agency is now seriously reconsidering the extension of compliance dates for the submission of product applications, particularly for flavored e-cigarettes.  “I believe certain flavors are one of the principal drivers of the youth appeal of these products,” said Dr. Gottlieb (in March 2018, FDA issued an advance notice of proposed rulemaking to seek public comment on the role that flavors in tobacco products play in attracting youth).

FDA issued letters to the five manufacturers comprising 97% of the e-cigarette market, asking them “to put forward plans to immediately and substantially reverse these trends, or face a potential decision by the FDA to reconsider extending the compliance dates for submission of premarket applications.” The letters stated that the sale of e-cigarette products to minors “is unacceptable, both legally and as a matter of public health.”  FDA requested that each manufacturer respond within 15 days including “a proposed timeline for meeting with FDA.”  Within 60 days FDA requested “a detailed plan, including specific timeframes, to address and mitigate widespread use by minors.”  FDA provided several plan elements for the manufacturers to consider, which included discontinuing sales to retailers that are subject to an FDA civil monetary penalty, reporting to FDA the name and address of retailers that have sold products to minors, eliminating online sales, and removing flavored products from the market until those products can be reviewed by FDA as part of a PMTA.  The letters stated that the actions proposed by the manufacturers would need to “demonstrate that FDA should continue to defer enforcement of the premarket review provisions” of the Tobacco Control Act (TCA).  FDA continued:

The youth tobacco use prevention imperative could affect the marketing of products that may have potential public health benefit for a different population, namely, cigarette smokers who may be seeking alternative forms of nicotine delivery. We recognize the challenge here. But steps must be taken to protect the nation’s young people.

Failure to respond to this letter may result in FDA taking action to enforce the premarket authorities in the TCA . . . .

FDA will review the information provided by your firm. If the agency determines that it should enforce the premarket authorization requirements in the TCA with respect to [your] products, we intend to communicate our expectations to you.

In other words, if FDA decides the actions are insufficient, it could require manufacturers to remove some or all of their products until they receive premarket authorization.

In addition, FDA committed to ramping up enforcement with a campaign to “monitor, penalize, and prevent e-cigarette sales in convenience stores and other retail sites” and “evaluating manufacturers’ own internet storefronts and distribution practices.” FDA intends to pursue appropriate enforcement actions if violations are found, including both civil and criminal remedies.  Furthermore, FDA will be “[i]nvestigating whether manufacturers of certain e-cigarette products may be marketing new products that were not on the market as of August 8, 2016 . . . .”  If these products are found to not have been on the market as of this date, they would fall outside of FDA’s compliance policy.

While the Commissioner did reinforce the Agency’s position that e-cigarette products may present an alternative for adult smokers to combustible cigarettes, the message to retailers and manufacturers is clear: reduce youth access and use or we will do it for you.

By Sara W. Koblitz & Kurt R. Karst —

After submitting five Citizen Petitions to FDA since 2016 (see Docket Nos. FDA-2018-P-2851; FDA-2017-P-4352; FDA-2017-P-3064; FDA-2017-P-1359; FDA-2016-P-0645) alleging that evidence does not support approval of opioids, Pharmaceutical Manufacturing Research Services (“PMRS”) is trying a new tactic to challenge FDA’s regulatory scheme for abuse-deterrent opioids: court.  PMRS is a contract manufacturer who appears to have been petitioning FDA to stop the approval of pending and future opioids indicated for chronic use.  Garnering little support from FDA, PMRS appears to have submitted its own 505(b)(2) NDA for an opioid with abuse-deterrent labeling: NDA 209155 for Oxycodone HCl Immediate-release Oral Capsules, 5 mg, 15 mg, and 30 mg.  But is it, as Admiral Ackbar uttered in Return of the Jedi, a trap?  (“It’s A Trap!”)

In February 2018, FDA published in the Federal Register a proposal to refuse to approve NDA 209155, and a Notice of Opportunity for a Hearing (Docket No. FDA-2018-N-0188).  FDA apparently refused to approve NDA 209155 based on a litany of deficiencies, including chemistry, manufacturing, and controls, GMP issues, failure to comply with patent certification requirements, impurity problems, and others.  FDA also noted that the product could not be approved with abuse-deterrent labeling because the application did not demonstrate the necessary abuse-deterrent properties.  PMRS responded with a timely Request for a Hearing, which FDA denied.  (As a side note – it is certainly not unusual for FDA to deny such a hearing, as FDA denies these hearings fairly often.)  PMRS responded to the denial with allegations of genuine and substantial issues of fact requiring a hearing, but FDA has not yet responded.

Rather than wait for another denial, PMRS decided to sue FDA.  In the Complaint, filed in the U.S. District Court for the Eastern District of Pennsylvania, PMRS alleges that FDA’s failure to have a hearing within the statutory period violates the Administrative Procedure Act and the Mandamus Act.  “Requiring PMRS to wait any longer for the hearing on its NDA to commence would be unjust, wasteful, and significantly harmful to the public health, because absent PMRS is being precluded from bringing its product to market with correct labeling, while other, mislabeled and dangerous opioids are permitted to proceed to market,” alleges PMRS in the Complaint.

But it seems from the Complaint that PMRS may be using this litigation as a bully pulpit to protest FDA’s framework for evaluating purported abuse-deterrent opioids.  Indeed, the 22-page Complaint dedicates 15 pages to discussion of the opioid epidemic, FDA’s reliance on Abuse-Deterrent Opioid guidance, “chronic use” labeling with abuse-deterrent claims, and the scientific evidence supporting the effectiveness of long-term opioid therapy for chronic pain. The Complaint also alleges that FDA improperly approved several opioids based on previous findings of effectiveness for referenced listed drugs, including Roxybond, Roxicodone, and Percodan.

Reviewing the Request for a Hearing raises the question of whether the entire NDA was submitted simply to contest FDA’s approach to abuse-deterrent and chronic use opioid approval. The Request for a Hearing challenges FDA’s regulatory approach rather than any specific deficiency in its application.  Given that PMRS does not appear to hold any approved drug applications, it is possible that this NDA was submitted to make a point – and to provide PMRS with standing to sue FDA for its review practices with respect to opioids.  If so, it is a creative – albeit expensive – strategy.  It’s difficult to say how far a court will let this go given that the FDC Act only requires FDA to give the applicant notice of an opportunity of hearing, but we don’t expect PMRS to give up quietly. Once final action is taken with respect to this hearing request, this NDA may serve as the basis for a lawsuit challenging FDA’s entire regulatory scheme for abuse-deterrent and chronic use opioids.

By Riëtte van Laack —

One of the main components of FDA’s 2016 final rule to update the Nutrition Facts is the mandatory requirement for a declaration and a daily value (DV) for “added sugar” for both sugars added to processed foods as well as foods “packaged as such,” including a bag of table sugar, jar of honey or container of maple syrup.  With respect to the single ingredient foods that are/contain sugars when “packaged as such,” FDA has acknowledged concerns by producers that this new labeling information may inadvertently lead consumers to think their single ingredient foods may actually contain added table sugar or corn syrup if “added sugars” are listed on the label. As we previously reported, FDA published a draft guidance in February 2018 in an effort to address this concern. In the draft guidance, FDA announced that it would allow the use of a symbol in the Nutrition Facts box on pure maple syrup and pure honey linking the added sugars daily value (DV) to a statement that would advise consumers about the meaning of the “added sugars” declaration.  Not surprisingly, FDA received a large number of comments on the draft guidance, many of which contended that FDA’s proposed approach would not prevent consumers from erroneously concluding that containers of pure maple syrup and pure honey contain sugar as an additional ingredient (and therefore are economically adulterated).

In June, just one day after closing of the docket for the draft guidance, FDA issued a statement that it would work with stakeholders to “swiftly formulate a revised approach that makes key information available to consumers in a workable way.”

Just recently, Commissioner Gottlieb issued what seems to be an interim response. On Sept. 6, 2018, the Commissioner announced that FDA is drafting the “final guidance, which [FDA] anticipate[s] issuing by early next year.” According to the Commissioner, this final guidance will provide an alternative under which, presumably, no declaration of added sugars will be required.  However, the Commissioner adds that FDA is “not considering changes to the required percent daily value for these products.”  No further details were provided.  How this will work remains to be seen.  For now, the manufacturers of single ingredient foods such as sugar, maple syrup and honey can be expected to hold off on revising their labels and wait for the final guidance to be issued in early 2019.

By Adrienne R. Lenz —

On September 6, 2018, FDA launched the Quality in 510(k) Review Program Pilot (“Quik”). With the name “Quik,” it has a lot to live up to.  The goal of the program is to simplify the 510(k) process by providing an alternate method of preparing a 510(k) using FDA’s eSubmitter software to format the submission. The new process is being piloted for a select list of device types. Eligible devices must also be reviewed by CDRH, not be classified as combination products and constructed with the eSubmitter template “non-In Vitro Diagnostic Device – 510(k).” The agency considers the eligible devices selected to be moderate risk and well-understood.

According to the user manual, the eSubmitter tool is “is intended to automate the current paper submission process, allowing for quicker completion once users are accustomed to the software, as well as speed up the filing process with FDA.” It can be set up locally or on a network, to allow multiple users to access a submission in process. Most of the documentation currently submitted in a 510(k) will be uploaded as attachments. However, some of the information will need to be entered into fields within the software. There may be challenges if content requires review from individuals outside of the network or if it is installed as a single user application.  From a practical perspective one can envision needing to maintain parallel working documents to exchange and review content prior to entering it into the application. This may actually add time to the 510(k) construction process. Once all information is entered, the eSubmitter packages the 510(k) in a file that is physically delivered to CDRH’s Document Control Center. A paper copy will no longer be required.

Submissions eligible for the program will be reviewed according to a faster timeline than a standard Traditional 510(k) submission. First, the Refuse to Accept review that typically occurs in the first 15 days of 510(k) review will not be conducted. (However, FDA will review the submission to confirm eligibility and will convert the submission to the standard procedure and timeline if the 510(k) is found to be ineligible.)  During the review, the submission will not be placed on hold.  All FDA requests for additional information will be made interactively with an expectation that the sponsor responds quickly.  The final decision is intended to be made within 60 days.

While requests for clarification of the device design or its testing can typically be made quickly, many 510(k) requests for additional information ask for additional testing when FDA feels that methods and/or data provided in the submission were insufficient. Sponsors may find it challenging to respond to such deficiencies quickly to allow a total review timeline of 60 days.  It will be interesting to see if the pilot program results in more sponsors needing to submit a second 510(k) if the first cannot be cleared within the timeframe.  In a current Traditional 510(k) review, FDA requests additional information around day 60 of their review and takes the remaining 30 days to review the additional information when submitted.  If sponsors find that multiple 510(k)s are required, the timelines will be increased as instead of a 30 day review after they complete the additional work, it will now be a new 60 day review. Also, a second user fee will be necessary.

For straightforward submissions that require only clarification or other updates that can be made quickly to address FDA requests, this program is likely to reduce overall review time. However, given many additional information requests take longer to respond to properly, the ability of a “Quik” 510(k) to reduce review times more broadly is unknown. We will follow this pilot program and provide updates on its outcomes as they become available.

By Riëtte van Laack —

On Sept. 10, 2018, the Food Safety Inspection Service (FSIS) of the USDA and FDA announced a joint public hearing scheduled for Oct. 23-24, 2018.

The federal register announcement, explains that this will follow a meeting by FDA’s Science Advisory Board on October 22, 2018. The advisory board will address questions prepared by FDA and USDA.  The intent is “to support a process for identifying potential hazards, assessing risks, and establishing control measures appropriate to each risk for cell cultured food products.”  As the questions are still being developed, further details will be provided at a later date.

The two-day public hearing is scheduled to address safety issues and jurisdictional issues on day 1 and labeling on day 2. Stakeholders will have an opportunity to provide oral comments during the public meeting as well as written comments to the docket. Comments previously submitted in response to the July 12, 2018 FDA public hearing need not be resubmitted.  FSIS and FDA jointly will review these and new comments.  In addition, according to the notice, time has been allotted for audience questions after most presentations delivered during the meeting.

Given the high level of interest early registration is recommended.

By Kurt R. Karst —

As we celebrate the 35th Anniversary of the Orphan Drug Act (see our 30th anniversary post here), periodic consideration of opportunities to reform and refine the approach to rare disease medical product regulation is warranted – similar to the review that occurred 10 years ago, which resulted in the establishment of the CDER Rare Diseases Program and first FDA public hearing on orphan drugs in June 2010.

In that spirit, Hyman, Phelps & McNamara, P.C.’s Frank Sasinowski (who serves as Vice Chair of the EveryLife Foundation Board of Directors) and James Valentine co-authored a proposal for building an FDA Rare Disease Center of Excellence (COE). The proposal will serve as a discussion document for the upcoming EveryLife Foundation 10th Annual Scientific Workshop. The proposal comes on the heals of the 21st Century Cures Act which provides FDA authority to establish COEs, as well as recent successes with the first COE in oncology.

The onus for this proposal, as well as the Scientific Workshop, is that because of the Orphan Drug Act, which provides incentives to make developing drugs for small numbers of patients financially viable, there has been increased investment in the research and development of medical products (drugs, biologics, and medical devices) to prevent and treat rare diseases, also known as orphan conditions. However, this influx has created unique regulatory challenges for FDA in providing regulatory oversight and in conducting review of marketing applications given that the development of products for these conditions present many unique challenges. There is no separate, lower or lesser legal or regulatory standard for approval of orphan products, so researchers and product developers and FDA alike must confront these issues throughout all phases of development and employ creative approaches to product development and review must be employed.

Given the unique challenges and, therefore, the unique expertise needed to advance the development and review of products for rare diseases, a Rare Disease COE would provide the necessary infrastructure to allow centers and offices across FDA to consistently and efficiently review novel products for these conditions. The proposed Rare Disease COE would involve a combination of three overarching organizational changes at FDA:

1. Establishment of a COE organizational unit within the Office of Medical Products and Tobacco with cross-Center responsibilities
2. Establishment of a Deputy Director for Rare Diseases within each review office/division across CDER, CBER, and CDRH
3. Establishment of a Rare Disease Advisory Committee

For more information on the details on the structure, function, and regulatory responsibilities of this Rare Disease COE, you can view the proposal here.

The EveryLife Foundation’s Scientific Workshop, which takes place this Thursday, September 13^th from 8:30 am until 4:00 pm has a robust agenda that brings together regulators, patient advocates, academia, industry, and other stakeholders to discuss both progress and continued challenges in the development and review of medical products for rare diseases. The day will culminate with a presentation by Mr. Sasinowski on this proposal for a Rare Disease COE, which will be followed by a panel discussion consisting of:

• Rich Moscicki, MD, Executive Vice President, PhRMA
• Paul Melmeyer, Director of Federal Policy, NORD
• Lucas Kempf, MD, Associate Director Rare Diseases Program, FDA
• Celia Witten, MD, PhD, Deputy Director, FDA CBER
• Alan Beggs, PhD, Director, The Manton Center for Orphan Disease Research

The workshop agenda can be found here, and you can register for the webcast is available here.

We hope this proposal and the workshop will initiate a dialogue about such possibilities to jumpstart brainstorming that may result in increased visibility for rare disease therapies and other related developments (e.g., a practical way to enhance and augment the prominence of surrogates and Accelerated Approval).

By Kurt R. Karst —

Back in June 2017, we introduced folks to a system we dubbed “ANDA Arbitrage.”  It’s an effort undertaken by a company called ANDA Repository, LLC to help companies potentially decrease annual user fee liability under the second iteration of the Generic Drug User Fee Amendments (“GDUFA II”).  Since then, we’ve hear the words “genius” and “entrepreneurial” used to describe the service.

As we quickly approach the October 1, 2018 deadline when the state of ANDAs solidifies and fee payments are due, we thought it would be a good time to remind some ANDA owners who have a small number of approved ANDAs, or who are just over the application count threshold for paying a higher ANDA Holder Program Fee, that there’s another option out there to consider.

GDUFA II significantly changed the user fee system and structure that had been in place under GDUFA I. Among other fees under GDUFA II, there’s the ANDA Holder Program Fee.  That fee is set up as follows: a firm and its affiliates pays one program fee each fiscal year commensurate with the number of approved ANDAs (both active and discontinued ANDAs) that the firm and its affiliates collectively own (see here).

The program fee to be paid each year depends on the number of ANDAs owned. Firms do not pay a per-ANDA fee.  Instead, the program fee is split into three tiers that represent different positions held by the firms and their affiliates within the market (i.e., small, medium, and large).  Specifically, FDC Act § 744B(b)(2)(E) states that:

if a person has affiliates, a single program fee shall be assessed with respect to that person, including its affiliates, and may be paid by that person or any one of its affiliates. The Secretary shall determine the fees as follows:

(I) If a person (including its affiliates) owns at least one but not more than 5 approved [ANDAs] on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a small business generic drug applicant program fee equal to one-tenth of the large size operation generic drug applicant program fee.

(II) If a person (including its affiliates) owns at least 6 but not more than 19 approved [ANDAs] on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a medium size operation generic drug applicant program fee equal to two-fifths of the large size operation generic drug applicant program fee.

(III) If a person (including its affiliates) owns 20 or more approved [ANDAs] on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a large size operation generic drug applicant program fee.

The statute (at FDC Act 744B(g)(5)) also includes certain penalties for failure to pay the ANDA Holder Program Fee:

(A) IN GENERAL.—A person who fails to pay a [ANDA Holder Program Fee] by the date that is 20 calendar days after the due date . . . shall be subject to the following:

(i) The Secretary shall place the person on a publicly available arrears list.

(ii) Any [ANDA] submitted by the generic drug applicant or an affiliate of such applicant shall not be received, within the meaning of section 505(j)(5)(A).

(iii) All drugs marketed pursuant to any [ANDA] held by such applicant or an affiliate of such applicant shall be deemed misbranded under section 502(aa).

(B) APPLICATION OF PENALTIES.—The penalties under subparagraph (A) shall apply until the fee required under subsection (a)(5) is paid.

For Fiscal Year 2019, the ANDA Holder Program Fee tier rates increased pretty significantly compared to Fiscal Year 2018:

That’s where ANDA Repository, LLC comes into the picture. . . .

Imagine a parking lot. The owner of a car that is not being used on a daily basis needs a parking space for that car.  In exchange for that parking space (and an annual fee) the car’s owner transfers title of the automobile to the parking lot owner.  The old owner of the car can, with appropriate notice, take back ownership when he decides that he wants to use the automobile again.  Provided the parking lot owner has enough cars, this can be a beneficial venture for all of the parties involved.

In the imagery above, the automobile owner is an ANDA sponsor (typically with a discontinued ANDA), and the parking lot owner and attendant is ANDA Repository, LLC. As a “large size” operation, ANDA Repository, LLC pays a flat ANDA Holder Program Fee regardless of how may ANDAs are owned.  In exchange for its services, ANDA Repository, LLC charges an ANDA sponsor an annual fee, which we understand is significantly less than the ANDA Holder Program Fee such ANDA sponsor would otherwise pay as a small or medium size operation.

If you’re interested in the program, you should reach out to ANDA Repository, LLC soon. The mechanism to communicate to FDA a transfer in ANDA ownership prior to October 1, 2018 should be relatively painless: (1) Transfer of Ownership Letters (Seller) and Acknowledgment of Transfer of Ownership letters (Buyer) to the Office of Generic Drugs; and (2) Email and call CDER Collections notifying them of the change in ownership.

By Anne K. Walsh & David B. Clissold —

A district court in Massachusetts scolded FDA for failing to meet a two-year deadline for issuing a final rule mandating color graphic warnings on cigarettes. This decision is important for the public health interests associated with the graphic warnings, but interesting for the loss dealt FDA under the Administrative Procedure Act (“APA”).

As background, the Family Smoking Prevention and Tobacco Control Act of 2009 required FDA to promulgate a final rule mandating color graphic warnings on cigarette packs and in cigarette advertising by June 22, 2011, i.e., two years after Congress enacted the statute. FDA issued a final rule within the two year time period requiring the use of nine text warnings accompanied by graphic images.  A group of tobacco product manufacturers and sellers promptly challenged the rule, alleging that it violated their constitutional right to free speech.  The district court agreed with industry, and the D.C. Circuit upheld the lower court’s decision and vacated the final rule in 2012.

A coalition of physician groups and cancer associations filed the instant suit to force FDA to follow the mandate of the Tobacco Control Act and issue new graphic warnings requirements. They alleged that FDA violated the APA because it “unlawfully withheld” agency action, or in the alternative, “unreasonably delayed” the final rule.  FDA explained to the court that following the 2012 D.C. Circuit decision, the agency formed a working group to research the text of warning statements.  In 2015, FDA contracted with a communications and marketing firm to develop new graphic warning image concepts that were tested in discussion groups.  FDA revised the warnings and then contracted a social science research firm to conduct focus group testing on the revised warnings.  FDA further modified the warnings in response to these results.  FDA explained to the court that additional research was being planned, including another round of focus group review, and two quantitative studies.  The research would then be used to support a formal rulemaking, which FDA estimated would conclude in November 2021.

The Honorable Indira Talwani agreed with the plaintiffs that FDA violated the APA because it both “unlawfully withheld” agency action, and “unreasonably delayed” the final rule.

“Unlawfully Withheld” Standard.  Plaintiff argued that the court should compel agency action here because Congress established a firm, enforceable deadline in the statute.  The district court agreed, highlighting the distinction that exists under the APA when the statute “impose[s] a date-certain deadline on agency action,” and not just a general admonition to act “within a reasonable time.”  The court found that FDA’s duty to promulgate a rule under the Tobacco Control Act is “nondiscretionary”: “Not later than 24 months after June 22, 2009, the Secretary shall issue regulations that require color graphics depicting the negative health consequences of smoking to accompany the label statements . . . .”  Even though FDA pointed to its original compliance with the two year deadline before vacatur, the court held that the vacatur “simply return[s] matters to where they stood before,” thus resetting the two-year clock.  The court stated that “it cannot be the case that the FDA has freed itself from Congressional mandates and may now take the opportunity to promulgate this rule at whatever pace it chooses.”

“Unreasonably Delayed” Standard.  The court also walked through the six TRAC factors, named after the D.C. Circuit Court case establishing the test for “unreasonable delay.”

1. the time agencies take to make decisions must be governed by a rule of reason;
2. where Congress has provided a timetable or other indication of the speed with which it expects the agency to proceed in the enabling statute, that statutory scheme may supply content for this rule of reason;
3. delays that might be reasonable in the sphere of economic regulation are less tolerable when human health and welfare are at stake;
4. the court should consider the effect of expediting delayed action on agency activities of a higher or competing priority;
5. the court should also take into account the nature and extent of the interests prejudiced by delay; and
6. the court need not find any impropriety lurking behind agency lassitude in order to hold that agency action is unreasonably delayed.

The court used reprimanding language in its opinion to describe the two year “detour” after the appellate decision vacating the final rule and the “gaps of time where little to no work was completed,” and noted that FDA’s current timeline proposes a period of “four times the initial amount of time set by Congress.” The court also noted that “FDA has not articulated a single higher priority” to justify the “competing priorities” required under the fourth TRAC factor, but requests that the court defer to FDA’s priority choices without regard to those dictated by Congress.  Thus, the court found there was “unreasonable delay” and ordered FDA to provide within three weeks (by September 26, 2018) an expedited schedule for issuing a final rule (including completion of studies, and notice-and comment rulemaking).  The court also offered time for plaintiffs to review and respond to FDA’s proposed schedule, and stated that it intends to direct further action following review of the schedule.

Given the deference typically afforded agencies in their statements of what is a reasonable timeline, this case is a notable win for challenges to agency (in)action. It will be interesting how much FDA’s new schedule shaves off its initial proposed deadline of November 2021, and whether FDA will use this “expedited” schedule as a basis for pushing other competing priorities on the backburner.