Pharmaceutical Manufacturing in Puerto Rico after Maria– Where does it go from here?

Pharmaceutical Manufacturing in Puerto Rico after Maria– Where does it go from here?

By Mark I. Schwartz – 
Puerto Rico has been a hub of pharmaceutical manufacturing for some time, but in the aftermath of hurricane Maria (and Irma), that has changed – at least for now. Without power in most of the island, but more importantly, without employees who can get to work on a regular schedule, much of Puerto Rico’s pharmaceutical manufacturing has been idled, and is likely to continue that way for some time.
According to the Bureau of Labor Statistics, pharmaceutical manufacturing represented 72% of Puerto Rico’s exports in 2016 ($14.5 billion), and the sector accounted for 25% of the total of U.S. pharmaceutical exports to the rest of the world. By comparison, California was next in line, but had only half as much in the way of pharmaceutical exports. 
Puerto Rico has more than 50 registered pharmaceutical facilities on the island, producing sixteen of the top twenty selling drugs in United States, and seven of the top ten selling drugs globally.
Its status as hub of pharmaceutical and biotech manufacturing has its origins in its tax favored status under the Internal Revenue Code, which, for decades, incentivized U.S. based manufacturers to send profits from the island’s plants to their stateside parent companies without having to pay federal taxes. In 1996, President Clinton signed into law an amendment to the Internal Revenue Code, phasing it out over ten years.  Several plants have shuttered since the phase out of this tax favored status, and with the devastation caused by hurricane Maria, analysts worry that several more will never reopen for business. 
Recognizing the impact that the shut-down of a large segment of the U.S. pharmaceutical industry can have on the supply of drugs to consumers (and hence on public health), FDA Commissioner Gottlieb has issued two statements (here and here) in recent days, emphasizing the importance of Puerto Rico to the continued success of the U.S. pharmaceutical industry (as well as on the importance of the pharmaceutical industry to Puerto Rico’s economic health), and on the efforts that are being made by FDA to identify and bring the island’s pharmaceutical resources back into operation.

Leading up to the storm, our team of shortage experts worked to identify and coordinate with companies that have manufacturing facilities in Puerto Rico to assess the potential impacts on their facilities to avoid—whenever possible—shortages of critical medical products. During and following the storm, we have worked with pharmaceutical and medical device firms to figure out whether manufacturing facilities were damaged, or if they were still operational and could continue to function on generator power. Since Friday, we have undertaken swift and extensive efforts to prevent or limit the loss or shortage of multiple drugs critical to American patients due to the challenges related to refrigeration, storage and transportation. The agency has been working closely – throughout the weekend and into today – to relocate products in coordination with our federal and local government colleagues and pharmaceutical companies.

The Commissioner also stated that he has directed the creation of a hurricane shortages task force that will be asked to identify potential issues and creative solutions to impending drug shortages, as the agency is aware of several other situations where there may be critical shortages “…if we don’t find a path for removal [of the drug products from Puerto Rico] or ways to get production back up and running.”
For all these reasons, we all hope that Puerto Rico’s recovery is swift and comprehensive.

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FDLI’s Introduction to U.S. Biologics and Biosimilars Law and Regulation

FDLI’s Introduction to U.S. Biologics and Biosimilars Law and Regulation

Hyman, Phelps & McNamara, P.C.’s Mark I. Schwartz will be presenting on the Regulation of Biological Manufacturing at the Food and Drug Law Institute’s (“FDLI’s”) Introduction to U.S. Biologics and Biosimilars Law and Regulation course, which is scheduled to take place from October 4-5, 2017 in Washington, DC.  A copy of the conference agenda is available here.
FDLI’s course is designed for new legal and regulatory professionals as well as seasoned professionals new to the topic or wanting a refresher.  The program explores the regulation of biological products, including biotechnology–derived therapeutic proteins, human tissue, gene, and cell products. Attendees will learn about the abbreviated pathway to market for biosimilar biological products and associated intellectual property issues, including exclusivity and biologics patent litigation. Case studies, hypotheticals, and ample time for Q&A are provided.
To learn more and to register for the conference, visit http://ift.tt/2xF6pHp. Use discount code “save15”  to save 15% off your registration fee.

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FDA’s Approach to Analytical Similarity for Proposed Biosimilars

FDA’s Approach to Analytical Similarity for Proposed Biosimilars

By Sara W. Koblitz –
Earlier this week, FDA published another in its series of guidance documents devoted to implementing the Biologics Price Competition and Innovation Act (“BPCIA”). The objective of the new guidance, entitled Statistical Approaches to Evaluate Analytical Similarity Guidance for Industry, is to assist sponsors in demonstrating analytical similarity to support licensure under section 351(k) of the PHS Act. This guidance is intended to serve as a companion document for Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to Reference Product (we blogged about this guidance here).
According to the guidance, analytical similarity involves the comparison of structural or physicochemical and functional attributes using multiple lots of the proposed biosimilar product and the reference product. Under PHS Act § 351(i), “biosimilar” means that the biological product is “highly similar” to the reference product licensed under PHS § 351(a) – even if there are minor differences in clinically inactive components, as long as there are no clinically meaningful differences between biosimilar and reference product safety, purity, and potency. This must be demonstrated based on “analytical studies.”  In this guidance, FDA details its current thinking on these analytical studies, including challenges a sponsor may encounter. 
FDA first addresses the challenges that may arise in attempting to demonstrate analytical similarity. These include a limited number of appropriate or representative reference product or biosimilar lots and the large number of attributes that can be compared to evaluate quality but may not actually be meaningful.
Thus, FDA recommends a risk-based approach in analytical similarity assessment of quality attributes. This approach involves an Analytical Similarity Assessment Plan.  A successful Analytical Similarity Plan will be based on testing with a minimum of 10 reference product lots, 10 biosimilar lots, representative samples of reference product variability (including expiry), U.S.-licensed reference lots only, and lots manufactured with different processes or scales.
The Analytical Similarity Assessment Plan itself should be based on a several step approach:

Step 1: Determine the quality attributes that characterize the reference product in terms of structural/physicochemical and functional properties.
Step 2: Rank these quality attributes according to risk of potential clinical impact.
Step 3: Evaluate these attributes based on three tiers of statistical approaches.

The intent of the analysis is to examine the potential impact on clinical performance and the degree of uncertainty around a clinical attribute in terms of risk to product similarity. Beyond risk, the level of impact of the attribute, the assays used for the attribute, and the types of attributes evaluated should all be carefully considered. 
Once the attributes are identified and ranked, the sponsor should determine the appropriate statistical methods to be used based on risk ranking. Tier 1 testing, or formal statistical equivalence testing, should be used for those quality attributes determined to have the highest potential clinical impact.  Tier 2 (called the Quality Metric approach), involves setting ranges of acceptable quality attributes and is best used for medium-impact attributes.  Finally, Tier 3, Visual Displays, involves subjective assessment through observation and should be used for those attributes with either the lowest risk of potential clinical impact or those attributes that are important but not amenable to formal tests or quantitative evaluation. 
FDA notes that final assessment of “highly similar” is made upon the totality of evidence rather than the passing or failing of the analytical similarity criteria of any one tier or any attribute. This demonstrates FDA’s willingness to show flexibility in applying a complex concept, which is necessary given the range of sizes and types of molecules eligible as biologic reference products.  Further, establishing biosimilarity is not a one-size fits all process, and this guidance is indicative of FDA’s case-by-case approach.  As with all drug development, both small and large molecule, FDA will be involved in the development program from the start – but this guidance gives industry the broad strokes to allow more productive planning conversations. 
 

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Regenerative Medicine Advanced Therapy: FDA’s Newest Expedited Program Evolves to Keep Pace with Recommendations

Regenerative Medicine Advanced Therapy: FDA’s Newest Expedited Program Evolves to Keep Pace with Recommendations

By James E. Valentine & Frank J. Sasinowski –
If you read our blog, you already know that the 21st Century Cures Act included a provision that created the Regenerative Advanced Therapy designation program, or “RAT” (see our previous coverage of the Act here).  You will also already know that the Center for Biologics Evaluation and Research (“CBER”) put forth its interpretation of the RAT designation program (see our previous coverage here).  What you may not know is that since that time, we’ve been busy making recommendations that we were hoping would be heard so that either FDA or Congress could improve the program.  Luckily, we have a couple changes to report.
A Name Change
Congress didn’t do FDA or industry any favors with the naming of the new designation program.  Nobody was excited to say their biologic product is a RAT! In HP&M’s January 12th webinar on the drug and biologics-related provisions of the 21st Century Cures Act, Frank Sasinowski made the pitch to rename the acronym.  Specifically, he proposed a reordering of the acronym lettering to ART, or Advanced Regenerative Therapy (see webinar slides 50-55 here).  While FDA didn’t initially propose to change the name of this designation program, sometime in early 2017 the Agency heeded this warning and changed the acronym to RMAT, or Regenerative Medicine Advanced Therapy (as reflected on CBER’s webpage here).  While the new name is a little redundant, it does the trick.
Inclusion of Gene Therapies
On a more substantive note, the 21st Century Cures Act language also left many of us in the advanced regenerative therapy industry scratching our heads.  The statute defined this new category of drugs to include cell therapies and therapeutic tissue engineering products, but not gene therapies.  Many of us felt that this must have been an oversight in the drafting of the provision, and that the legislative intent was surely to include gene therapies.  However, the webpage CBER created to implement the designation program did not add any clarity on this topic.  To thwart any differences in statutory interpretation between stakeholders, and to ensure predictability in the application of the designation, at the Rare Disease Congressional Caucus briefing held on March 2nd, Frank Sasinowski recommended to members of Congress and their staffs to make a technical amendment to explicitly include gene therapies in the definition of advanced regenerative therapy (see previous coverage of this briefing and Sasinowski’s slides here).
Congress did not take such action, despite having a chance to add a technical amendment with the passage of the FDA Reauthorization Act (“FDARA”) over the summer (see our firm’s detailed summary and analysis of FDARA here).  Instead, on August 28, 2017, FDA Commissioner Scott Gottlieb, M.D. announced, as part of a speech on oversight of stem cell therapies and regenerative medicine, the Agency’s “plan to include certain gene therapy products that permanently alter tissue and produce a sustained therapeutic benefit as part of the products that will meet the definition of being eligible to come under the pathway enabled by RMAT” (see the full statement here).  This new policy provides clear guidance that the door is open for RMAT designation to gene therapies.

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Court Deals Blow to Mysteriously Named Whistleblower, and Blows off Precedent

Court Deals Blow to Mysteriously Named Whistleblower, and Blows off Precedent

By Anne K. Walsh & Andrew J. Hull –
Earlier this month, the U.S. District Court for the Central District of California dismissed a qui tam complaint filed against Medtronic and its subsidiaries alleging violations of the False Claims Act (FCA).  The relator (an LLC named “The Dan Abrams Company LLC” formed by a former Medtronic employee named Bryan Shapiro) alleged, inter alia, that Medtronic obtained marketing approval for some of its spinal implant products by deceiving FDA as to the intended use of these products, and that Medtronic promoted these products for an off-label use.  As a result, the relator alleged Medtronic caused the submission of false claims to CMS under an implied false certification theory.  The government declined to intervene.
The court’s discussion on the lack of grounds for the relator’s qui tam complaint is significant, particularly for device manufacturers facing fraud-on-FDA or off-label promotion claims under the FCA.
Regarding Medtronic’s alleged fraud to obtain clearance for its devices, the relator claimed that certain devices were designed for a use (cervical) other than the use for which Medtronic sought clearance (thoracolumbar). The court rejected this allegation, noting that FDA may grant 510(k) clearance with labeling limitations if FDA is concerned that a product may be used off-label. See FDC Act § 513(i)(1)(E).  The relator’s claim that a cleared device was actually intended for an off-label use was not itself sufficient to support a claim of improper clearance.  The court explained that “claims of fraud are disfavored if made by third parties who seek to second guess a decision by the FDA to certify a device,” Slip Op. at *8, and it noted that FDA has the enforcement jurisdiction and means necessary to “police” FDC Act violations.  The court cited the First Circuit D’Agostino decision (see our previous post here) to support its holding that an FCA action is an inappropriate tool against allegations of fraud on FDA. Id. at *9. 
Surprisingly, the court did not reference the Ninth Circuit’s Gilead Sciences decision from this summer (see our previous post here) that cursorily held that similar claims were supported in the relator’s complaint. In that case, the Ninth Circuit rejected the rationale in D’Agostino and held that allegations of false statements and false conduct by the manufacturer to obtain approval of a drug were adequate to support an FCA claim (at least at the motion to dismiss stage).  As we previously blogged, the company in that case has filed a petition for rehearing or rehearing en banc (still pending), and several industry groups have filed briefs in support of the defendant.
The court dismissed the relator’s off-label promotion theory on the ground that CMS may cover a cleared device used off label if the use is “medically necessary” or “reasonable and necessary” to treat a specific patient. Id. at *10.  Specifically, the allegations “must be sufficient to support the claim that the [devices] were unsafe, untested or otherwise unfit for the purposes for which they were used, and that Defendants nevertheless knowingly promoted them.” Id. at *11.
Unlike other recent cases, the court brushed over the Escobar materiality issue, with little discussion or analysis of what constitutes a “material” false claim.  Medtronic had argued that there could be no materiality where the amount paid by CMS for a spinal surgery is not affected by whether Medtronic’s products were used and where CMS contractors would not know whether one or more of the devices had actually been used in a particular surgical procedure.  The court dismissed these arguments for purposes of Medtronic’s motion, explaining that CMS may still have assigned values to devices “that have been approved through an FDA process.” Id. at *11.  The rationale is confusing, however, and assumes an FDA value-assignment process that is not described in the FDC Act or FDA regulations.
While the court granted Medtronic’s motion to dismiss, it did so without prejudice. Relator may file an amended complaint by October 2, 2017.

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Public Citizen Suit Highlights FDA’s Delays in Updating OTC Drug Monographs

Public Citizen Suit Highlights FDA’s Delays in Updating OTC Drug Monographs

By Jennifer M. Thomas –
Public Citizen sued FDA last week, in an effort to force Agency action on the tentative final monograph (“TFM”) for OTC oral health care drug products. That TFM currently permits the marketing of OTC benzocaine oral health care drug products labeled for use to relieve infant teething pain. On July 28, 2014, Public Citizen petitioned FDA to (1) reopen the OTC oral health care drug monograph, (2) revise the labeling requirements for benzocaine products to preclude indications for infant teething pain, and (3) require warning labeling on benzocaine products about the risk of methemoglobinemia, a rare but potentially serious blood disorder that can be caused by exposure to benzocaine. Effects of methemoglobinemia can include developmental delays, intellectual disabilities, seizures, or coma, among other things. FDA has yet to act on Public Citizen’s petition.
FDA’s TFM for oral healthcare drug products was issued in 1991. At that time, FDA’s advisory review panel “recognized that benzocaine could be linked to methemoglobinemia and that infants were more susceptible to that condition” (Compl. ¶ 16), but determined that a warning label was not necessary. According to Public Citizen, data on the link between benzocaine’s use as an anesthetic in teething infants and development of methemoglobinemia continued to accumulate after the TFM was published. So much so, that between 2003 and 2014, FDA “issued multiple safety announcements related to the risk of methemoglobinemia with OTC benzocaine products” based on adverse events reported to the agency. Id. ¶ 20, see also, e.g., FDA Consumer Update. In 2014, FDA also encouraged manufacturers to voluntarily include a methemoglobinemia warning on their benzocaine products, even though such a warning would fall outside the label specifications set forth in the TFM. Yet, FDA did not grant or deny Public Citizen’s petition – stating in February 2016 that it was unable to do so in light of the “significant/complex issues [raised by the petition] requiring extensive review and analysis by Agency officials.” Compl. ¶30.
Public Citizen’s suit faces an uphill battle, given courts’ traditional reluctance to force FDA’s hand with respect to either the substance or the timing of regulatory decisions grounded in science. While the gravity of this issue and FDA’s administrative record are factors in Public Citizen’s favor, the complaint lacks examples of benzocaine products currently on the market bearing indications for use in infant teething, and does not allege that Public Citizen’s members or their children are exposed to infant teething products containing benzocaine. Thus, FDA and the court might reasonably question Public Citizen’s claim to standing in the case.
Public Citizen’s lawsuit also highlights the significance of FDA’s ongoing discussions with industry about updating the OTC drug monograph program to make it more efficient, and the need for an OTC drug monograph user fee program. From that perspective, FDA and proponents of a user fee program may welcome litigation that draws public attention to the Agency’s lack of necessary resources to review and update OTC drug monographs.

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CDRH Issues Final Guidance Regarding Interoperable Medical Devices

CDRH Issues Final Guidance Regarding Interoperable Medical Devices

By Allyson B. Mullen –
On September 6, 2017, FDA issued the final guidance “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.” The final guidance can be found here. The document provides guidance regarding interoperable devices, which it defines as devices “that have the ability to exchange and use information through an electronic interface with another medical/non-medical product, system, or device.”  FDA issued a draft of this guidance on January 26, 2016.  We previously blogged on the draft guidance here.
The final guidance is generally unchanged from the draft. There are, however, a few notable differences:

The final guidance acknowledges that design considerations may be different for different types of devices. This is a good sign that FDA acknowledges that interoperability is not a one-size-fits-all requirement.
The final guidance includes an additional design factor to consider regarding interoperability, “the transmission of metadata (e.g., unique device identifier (UDI), software version, configurations, settings).”
With regard to the anticipated users, the guidance adds that “patients may need specific instructions on how to use their device in a home environment.”
The final guidance emphasizes the need to perform risk analysis. For certain devices, FDA currently requests the risk analysis as part of the 510(k) submission. It will be interesting to see if FDA begins asking for the risk analysis for interoperable devices.
With regard to the types of verification and validation that a manufacturer should perform, the final guidance includes two additional points to consider, “assur[ing] that reasonably foreseeable interactions do not cause incorrect operation of other networked systems; and conduct[ing] testing that simulates real-world use of the device.”
The final guidance indicates that labeling considerations with regard to interoperability can be addressed through “materials within the package of the device, the instructions for use, or device-specific information posted on the manufacturer’s website.” (emphasis added.) FDA’s authority to regulate information on a company’s website as labeling is not clear cut. Therefore, it is interesting that the guidance makes such an affirmative assertion that labeling statements regarding interoperability may appear on a company’s website.

One final interesting point to note, the final guidance includes the following statement:

FDA recognizes and anticipates that the agency and industry may need up to 60 days to perform activities to operationalize the policies within the guidance. If new information regarding device interoperability as outlined in this guidance is not included in a premarket submission received by FDA before or up to 60 days after the publication of this guidance, CDRH staff does not generally intend to request such information during the review of the submission.

While it is generally understood, at least in industry, that it takes time to comply with new FDA guidances, it is unusual for a guidance to expressly allow for a lead-in period. However, in some instances, the Agency has been in a hurry to implement new guidances.  We think this language is a good sign that FDA is acknowledging that it will take time for manufacturers to comply with new guidance (even though the guidance is not technically binding).  

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FDA to Hold Meeting on Home Collection of Pap Smears: Possible Broader Implications?

FDA to Hold Meeting on Home Collection of Pap Smears: Possible Broader Implications?

By Jeffrey N. Gibbs & Allyson B. Mullen –
The reduction in the rate of cervical cancer is one of the great success stories in public health.  The introduction of the Pap smear and human papillomavirus (HPV) testing has led to a significant reduction in the rate of cervical cancer.  However, there are still gaps in cervical cancer screening.  FDA will hold a public workshop early next year to talk about the possible use of a new measure to improve screening: self-collection of samples.
In its September 8 Federal Register notice announcing the meeting, [LINK HERE] FDA noted that “gaps in cervical cancer screening exist.”  The agency explained, “Barriers to cervical cancer screening may include limited access to such service in rural areas, socioeconomic status, etc.”  FDA is undoubtedly correct that cervical cancer screening rates can be and should be improved, and that there are non-medical barriers to increased testing.
The announcement is obviously significant for companies involved with cervical cancer testing.  The adoption of self-collection tests could expand the volume of HPV testing and Pap testing.  Moreover, this creates a potential market opportunity for companies that can make the self-collection devices.
However, the implications of the public workshop potentially go well beyond the field of cervical screening.  Many companies have wanted to pursue self-collection of diagnostic specimens by consumers for a variety of analytes and conditions.  Obtaining FDA clearance for those products has not been easy.  The upcoming workshop may shed some useful light on how companies can better position themselves to enter the market for self-collection devices for other diagnostic purposes.  At a minimum, the meeting should provide insights into issues that FDA thinks are key: “how such devices should be dispensed to end users of self-collection, proper use of the device to ensure patient safety, the collection of adequate samples for testing, the use of these test results in patient care, and the impact on the current regulatory framework.”  Those questions transcend the specific use of home-collection in cervical cancer, and apply more broadly to home-collection devices for a wide range of applications. Indeed, FDA’s consideration of OTC collection to reduce “barriers” could have implications for OTC devices generally.
Getting self-collection devices through the FDA will probably not be quick or easy, no matter what happens at the workshop. Nor is the workshop likely to lead to any change in policy by itself, and it probably won’t provide any answers at all. Still, it may illuminate some broader policy and regulatory issues for a wide range of diagnostic tests – and possibly even other devices.  That discussion could have repercussions far beyond cervical cancer screening.

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Fifth Circuit Upholds Summary Judgement for Solvay Pharmaceuticals in Off-Label and Anti-Kickback FCA Case

Fifth Circuit Upholds Summary Judgement for Solvay Pharmaceuticals in Off-Label and Anti-Kickback FCA Case

By Jennifer M. Thomas & Andrew J. Hull –
It is the False Claims Act (FCA) case that wouldn’t die. The complaint in United States ex rel. King v. Solvay Pharmaceuticals, Inc. was originally filed in 2006 in the U.S. District Court for the Southern District of Texas. Through a series of partial summary judgment rulings, the District Court finally dispensed with the case (in Solvay’s favor) in March 2016. But the matter didn’t end there, as Solvay sought costs under 28 U.S.C. § 1920, and relators John King and Tammy Drummond appealed the District Court’s decision on both the merits and the award of costs to the Fifth Circuit. Now it appears the case may finally be at an end, with a Fifth Circuit ruling that upholds the District Court’s judgment in full, including $232,809.92 in taxable costs awarded to Solvay.
By way of background, the relators alleged that Solvay engaged in the off-label marketing and distribution of three drugs (Luvox, Aceon, and AndroGel) in violation of the FDC Act and the Anti-Kickback Statute (AKS). After federal and state governments declined to intervene in the case against Solvay at the District Court level, the District Court determined that relators John King and Tammy Drummond had not overcome the FCA’s public disclosure bar (a jurisdictional bar at the time) with respect to AKS/FCA claims associated with AndroGel, because they failed to establish their status as original sources of the information on which the claims were based. The District Court further held that relators had failed to sufficiently demonstrate that either Solvay’s alleged off-label marketing of Luvox and Aceon, or lobbying of state P&T committees and third-party publisher DrugDex regarding those drugs, actually caused the submission of false claims to the government.
After an exhaustive review of the evidentiary and other determinations made by the District Court, on September 12, 2017, the Fifth Circuit agreed with the District Court and upheld its disposition of the Solvay case. Evaluating the summary judgment decisions de novo, the Court held that there was no genuine issue of material fact as to whether the relators were original sources, or as to the causation evidence (or lack thereof). Relators had failed to establish, beyond mere speculation, that alleged “kickbacks” had caused the submission of false claims, or that off-label marketing had produced such claims, despite some evidence of a widespread off-label marketing scheme that relators alleged necessarily must have resulted in false claims.
Most interesting to us is the Court’s discussion of the difficulty of meeting the materiality standard in off-label promotion cases. We have been following how different federal courts around the country have been applying the Supreme Court’s materiality requirements discussed in its 2016 Escobar decision in the FDA regulatory context (see some of our previous posts here, here, here, and here). In this case, the Court latched onto a comment from a discussion that occurred during oral argument regarding the fact that Medicaid “pays for claims without asking whether the drugs were prescribed for off-label uses or asking for what purpose the drugs were prescribed.” Slip Op. at 13 n. 9. The Court noted that “[i]f this is true, given that it is not uncommon for physicians to make off-label prescriptions, we think it unlikely that prescribing off-label is material to Medicaid’s payment decisions under the FCA.” Id. (citing Universal Health Servs. Inc. v. United States ex rel. Escobar, 136 S.Ct. 1989, 2003-04 (2016)). This position, if widely accepted, would strike a blow to many future FCA cases involving the alleged off-label marketing of drugs or devices.
Finally, the Fifth Circuit approved the lower court’s award of taxable costs to Solvay under 28 U.S.C. § 1920 and Fed. R. Civ. P. 54(d)(1), while recognizing that the award amounted to “a fraction of the nontaxable expenses borne by litigants . . . .” An award of costs to defendants in these cases is rare, and helps serve as a check on overeager relators filing qui tam complaints without adequate legal or factual support.
Although relators could petition for rehearing or hearing en banc, and have 90 days (until December 11) to file a petition for writ of certiorari on any of the merits issue or on the award of costs, we think the possibility of further review is unlikely.

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Webinar: FDA Medical Device Submissions – You’ve Got Legal Questions – We Have the Expert

Webinar: FDA Medical Device Submissions – You’ve Got Legal Questions – We Have the Expert

Hyman, Phelps & McNamara, P.C.’s Jeffrey N. Gibbs has teamed up with MassMEDIC and Right Submission of to bring you a free webinar, titled “FDA Medical Device Submissions – You’ve Got Legal Questions – We Have the Expert,” that focuses on legal questions you might have relative to FDA product submissions.  You can register for the webinar here.  It will take place on September 27, 2017 from 12:00 pm – 1:00 pm (Eastern).
Questions such as:

From a legal perspective what are common mistakes submitters make in FDA submissions?
What recent legal cases has CDRH been involved in and how have they turned out?
Is the confidentiality text we copy-paste into our submissions legally binding and what happens if we don’t include it?  When should we include it?

This is an extraordinary opportunity to get your legal questions about FDA device submissions answered.  You can submit your own questions by email (info@massmedic.com) in advance of the webinar and they will be posed anonymously during the webinar.  Or send them to during the webinar.
Moderator: Juan Carlos Serna, Co-Founder & CEO, Right Submission Presenter: Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara

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