Life Sciences’ September Surprises

The October surprise may be the stuff of electoral legerdemain, but drug and device makers are seeing a few interesting legal twists inside and outside the courtroom in the month of September. In one instance, PMA preemption is back in the news, while another story involves what seems a very generous sale of intellectual property assets forced by multiple patent challenges.

Lassoed Again by the Riata

Despite best intentions, sometimes an old drug or device comes back to haunt its maker. This would appear to be the case with the Riata and Riata ST series of electrophysiology leads made by St. Jude Medical, now a subsidiary of Abbott. While this seems a fairly typical preemption case, Connelly v. St. Jude Medical seems to revive the issue of a litigant’s access to confidential commercial information.

According to documents from the U.S. District Court for the Northern District of California, Richard Connelly received a total of three Riata leads between 2003 and 2015. Connelly’s attorneys argued liability on the basis of manufacturing defects, failure to warn, negligence and negligence per se, and Abbott responded that the first three claims are explicitly preempted while the last is truncated by implied preemption.

Judge Edward Davila rejected the failure to warn claim, albeit with a possible amendment of the claim, the same determination he came to regarding the negligence per se claim. Avila gave the plaintiff until Sept. 8 to amend those claims, which apparently his counsel has done.

However, Avila affirmed the manufacturing defect claim partly because the plaintiff’s attorneys had no access to the entirety of the documentation for the regulatory filing. The basis of the manufacturing defect argument commenced with three pieces of evidence; an FDA inspectional form, the recalls of the Riata series of devices, and an internal root cause analysis undertaken to examine the lead insulation problems.

Avila wrote that California state law does indeed run parallel to federal law on the manufacturing defect issue because the plaintiff had demonstrated “a plausible connection between the alleged manufacturing defect and his injuries.” He based this conclusion in part on a 2014 case in the U.S. District Court for the Northern District of New York, Rosen v. St. Jude, but not much else.

Avila conceded that the Court of Appeals for the Ninth Circuit “has not directly addressed this issue,” but states that a plaintiff’s inability to access confidential commercial information at the time complaint was filed – coupled with factual evidence presumed to be sufficient to demonstrate a causal connection – are all that is needed to sidestep federal preemption and satisfy the requirements of Twombly.

The negligence claim survived on essentially the same set of facts, and the court determined that Abbott is not liable in this instance because its acquisition of St. Jude was not completed until after Connelly was injured. Avila indicated that the plaintiff can amend the complaint on this point as well, however. It seems fairly plausible that this case will end up in Ninth Appeals, regardless of the outcome in this venue.

Allergan’s IP End Run

Most methods for dealing with patent challenges run to the tried and true, but Allergan’s move to insulate its patents for Restasis may have left some members of the patent bar a bit dewy-eyed for not having thought of it themselves.

Allergan has declared it will transfer all patent rights for the treatment for dry eye to the St. Regis Mohawk Tribe, which will confer sovereign immunity on the related patents. This would seem to fend off ongoing challenges via the inter partes review process at the Patent and Trademark Office, but there are suggestions that Allergan has progressively less to lose. While sales of the product exceeded $350 million in the third quarter of 2016, the FDA has yet to decide whether generic versions will have to go through clinical trials in a debate between the agency and the manufacturer that is now in its fourth year.

The company is also fending off a patent challenge in the patent rocket docket in Marshall, Texas, over the production of generics, which some believe will hit the market as early as 2019. The problem for Allergan in this lawsuit, at least in terms of optics, is that the company has already settled with Famy Care Ltd., which will be able to market its generic version no later than 2024 (when the patent expires), and possibly substantially earlier.

Under the terms of the licensing agreement, the St. Regis Mohawk Tribe seems to be doing quite well, indeed, explaining in a Sept. 8 statement that it will receive more than $13 million from Allergan to take ownership of the patents in addition to an expected annual sum of $15 million in royalties.

Cardiaq Sustains Narrow Win Over Neovasc

The patent scrum between Cardiaq Valve Technologies and Neovasc Inc., made it all the way to the Court of Appeals for the Federal Circuit, which has affirmed a district court decision awarding the plaintiff more than $110 million. In Cardiaq Valve Technologies v. Neovasc, Inc., the plaintiff alleged that Neovasc had breached a contract the two companies had signed as part of a development program by Cardiaq toward a transcatheter mitral valve technology, which Neovasc purportedly violated by using some of the intellectual property in an effort to develop its own mitral valve device.

In addition to the initial jury damages of $70 million, Neovasc will have to pay roughly $20 million each for interest and enhanced damages, although neither the district court nor the Federal Circuit agreed to enjoin Neovasc’s development program. While Cardiaq won’t enjoy the kind of exclusivity typically afforded by a patent, it was acquired by Edwards Lifesciences, which has a degree of credibility with cardiologists that Neovasc cannot possibly match in the near term. Thus, while the patent fight seems uncomfortably close to a draw for plaintiff, the physician adoption curve is nearly certain to favor Cardiaq by a wide margin.

Of Pens, Delays, and Balloons

Some stories in the life sciences are years in the making while others take a more swift course to resolution. Below are three stories of varying degrees of persistence, but it may be that we have not heard the last of any of them just yet.

EpiPen Settlement a Sore Spot for Some

The EpiPen settlement between Mylan and the Department of Justice is finally in the books, but there were several interesting developments involved in this action, which has spanned at least the better part of a decade. The company has agreed to pay $465 million to settle these allegations, but there are indications that this matter is not finished.

To recap, the EpiPen controversy was already the subject of federal government interest in 2009, when the Office of Inspector General at HHS cited the Epipen as a product of interest in a report on the accuracy of drug prices for Medicaid rebates. The Aug. 17 DoJ statement announcing the settlement said Mylan had “violated the False Claims Act by knowingly misclassifying EpiPen as a generic drug to avoid paying rebates,” but the DoJ nonetheless stated that the claims “settled by this agreement are allegations only, and there has been no determination of liability.”

The department’s announcement lists only one relator in this qui tam action, Sanofi-Aventis, but Ven-a-Care of Key West, Fla., was also on board. Ven-a-Care is purportedly a pharmacy, but some see the company as more of a bounty hunter, given the frequency with which its owners avail themselves of large sums for similar cases. Thus, the Mylan case was driven by two relators rather than the more typical single relator, suggesting the data provided by Ven-a-Care and Sanofi were substantially different.

Another interesting facet of this case is that non-governmental 340B drug programs will enjoy rebates from the action, which is not ordinarily the case. In any event, this settlement might not be the last word on the controversy as Sens. Chuck Grassley (R-Iowa) and Richard Blumenthal (D-Conn) have criticized the amount of the damages as grossly inadequate.

The drug pricing controversy is providing plenty of whiplash for Valeant as well. Recently, Valeant investor Lord Abbett & Co. filed suit in New Jersey with the argument that Valeant’s actions violate that state’s Racketeer Influenced and Corrupt Organizations law. Should a judge accept that argument, Valeant could face treble damages.

340B Final Rule Delayed Again

In spite of all the consternation about drug prices, the Department of Health and Human Services has announced that it will once again delay a rule that would have dinged drugmakers for overcharging several types of institutions, including safety net hospitals.

The related provisions of the Affordable Care Act had expanded the types of institutions eligible for participation in the 340B program to include children’s hospitals and free-standing cancer centers, but the latest 340B final rule would have hit drugmakers with a $5,000 fine for each instance in which the charge for a drug exceeded the ceiling price. This is the third time the implementation date of this final rule has been pushed back, which is now suspended until at least July 2018. The move was blasted by a number of affected entities, but there are rumblings that the 340B reporting portal administered by the Health Resources and Services Administration is not fully operational.

Rates for Drug-Coated Balloons may Crater

A Medicare advisory board will recommend that the Centers for Medicare & Medicaid Services allow reimbursement for drug-coated balloons (DCBs) to lapse to the rates paid for standard angioplasty of the lower limbs. The decision flew in the face of clinician input, but whether CMS will go along with the advisory panel’s recommendation is not yet clear.

The Medicare advisory board for the outpatient prospective payment system said the rates paid for DCBs – such as Medtronic’s Admiral InPact and the Lutonix by C.R. Bard – should be allowed to fall to the rates paid for standard angioplasty balloons used in the femoral and popliteal arteries. DCBs enjoyed a higher reimbursement rate under the Medicare new technology pass-through program, but these devices have used up their eligibility for the program. This predicament leaves Bard and Medtronic facing a rate as low as $4,999 in calendar year 2018, a rate that clinicians said would impede access and possibly trigger a spike in the amputations DCBs are credited with preventing.

Physicians have argued that the use of a DCB requires both pre- and post-dilatation of the target vessel with a plain balloon to achieve the desired effect on vessel patency, a necessity that boosts both procedure time and costs. An industry representative suggested a rate closer to $8,000 for DCBs, but the panel clearly was not amenable. The panel endorsed a proposal that CMS track costs and utilization of these devices in CY 2018 in order to evaluate whether a new ambulatory payment classification code is needed to account for the costs associated with DCBs, but that proposal leaves patients and physicians with a 12-month question mark.

In the meantime, hospitals and other institutions will have to decide whether to take the financial hit for these devices in an effort to avoid readmissions, which are squarely in CMS’s crosshairs via several well-known health care delivery reform programs.

Going Solo, and Who Needs Government Anyway?

Some days it seems the idea of interdependence is really gaining ground, but then there are days that seem to trash the idea completely. Below are a couple of stories of the latter variety, stories that might seem more pointed to the diversity ethic that is also very much in vogue in these early years of the 21st Century. First, however, we ask whether the FDA’s device center is losing its appetite for heavy-handed regulation.

FDA Going Soft on Software?

The Center for Devices and Radiological Health at the FDA was pretty quiet for the first half of the year, but is a little more active recently. For instance, CDRH published a digital health action plan in response to pressure from Congress, but the plan is also a tacit admission from the agency that its quality systems regulations (QSRs) don’t always work well where software is concerned.

The reader may remember the FDA’s interest in medical device data systems dating back to 2011. Hospital administrators were wary of the cost and hassle of standing up a QSR-compliant regime in the first place, but four years would pass before the agency renounced the idea, undoubtedly with the help of some arm-twisting from Capitol Hill.

The FDA’s digital health innovation action plan includes a precertification pilot that calls for a review of a publisher’s approach to software quality control rather than a full-blown premarket review of each product. The program is limited to items that qualify as software as a medical device (SaMD), however, and excludes items such as software integrated into devices.

The precertification pilot does include site visits, but the agency is willing to conduct virtual site visits in lieu of the real thing. Ergo, one can argue that this is QSR-lite at worst. Still, one has to wonder how much time will pass before an SaMD will start pushing the FDA’s safety and efficacy buttons despite FDA commissioner Scott Gottlieb’s assertion that the program is strictly for “certain lower-risk devices.” That lower-risk assurance seems odd, given that the sponsor will be on the hook for collecting post-market data for that product.

The day one of these calls for a de novo application might herald a time when the agency will scrutinize these SaMDs individually, but how long after that will a sponsor discover they have tripped the class III/PMA trigger? Only time will tell.

Disharmony from Asia

Some see global regulatory harmonization as a pipe dream, and India’s Central Drug Standards Control Organization has released a draft guidance dealing with standards for safety and performance of medical devices that would seem to support that view. This document, which supplements a novel regulatory framework specific to med tech in India, suggests that CDSCO will handle stand-alone software in the same manner as traditional medical devices despite the FDA’s hands-off approach.

CDSCO gave interested parties only three weeks to comment, hardly sufficient time to absorb the implications of such a document, particularly since the document is undated, other than to note the month of publication (July). The agency said it does not want to dictate how a device maker might demonstrate compliance, but the scope of the 27-page document encompasses a wide range of product categories, including combination products, a breadth of scope which might come across to some as lack of specificity disguised as flexibility.

In any case, the document also takes aim at devices “that incorporate software and stand-alone medical device software,” which is where it rubs up against the new approach at FDA in a disharmonious manner.

As noted above, the American regulator is steering an entirely novel tack for its regulation of SaMD, which had said last year would revolved around a guidance drafted by the International Medical Device Regulators Forum. India is not a participant in the IMDRF effort, although it is a member of the Asian Harmonization Working Party (AHWP), which is an IMDRF affiliate and which has inked its own SaMD proposal, said to be built around the IMDRF effort.

One way of looking at this is that the FDA is the outlier and that the disharmony is coming from Silver Spring, Md., and not from New Delhi, although it may be instructive to note that the latter has a very limited body of experience with med tech-specific regulations. Either way, publishers of SaMD will continue to face very different regulatory regimes if they want to do business in both the world’s richest market and its second most populous market.

No DOJ? No Problem

As is commonly known, the Department of Justice does not dive head first into every qui tam action that pops up, but government attorneys seem to be involved in nearly every whistleblower suit that costs the target company money. Celgene of Summit, N.J. offers the exception, getting stung with a $280 million hit in a False Claims Act case that asked the federal government to do nothing more than accept a nice, fat check from the company.

The company denied any culpability, and Celgene may have a case given that the Centers for Medicare & Medicaid Services is somewhat more lenient about off-label use of oncology drugs. However, court documents indicated that Celgene helped patients financially by contributing money to two patient-directed organizations, which were said to have “acted as conduits for Celgene” and thus had “eliminated any price sensitivity” for both patients and prescribing physicians.

The court also said “the United States did not intervene” without comment, although the court pointed to two other qui tam actions against the company, both of which were dismissed.

The biggest problem for Celgene might have been that the company purportedly persuaded physicians to influence guidelines published by the National Comprehensive Cancer Network, and was alleged to have “caus[ed] doctors to change ICD-9 diagnosis codes.” The lay person sitting in a jury box might find it difficult to hear of manipulation of codes used in Medicare billing without thinking the source of that manipulation was up to no good, particularly given how much very visible emphasis there is these days on Medicare fraud.

Boomerang: EMA Goes from Hunter to Hunted

Boomerang: EMA Goes from Hunter to Hunted

Regulatory agencies spend more time investigating others than being investigated by others, but the European Medicines Agency is now on the hot seat over what is purported to be a lack of transparency regarding premarket interactions between it and drug makers. This is quite a reversal of the typical dynamic, such as when the EMA orders drug makers to withdraw their products from the EU market, but companies in the life sciences might not think the agency’s new transparency problem is a good problem for industry.

EU Ombudsman Investigating Presubmission Meetings

Allegations that regulators are all to cozy with industry are typically leveled at the American FDA, but that problem seems to have migrated to the other side of the Atlantic Ocean. Former journalist Emily O’Reilly, who took the job of European Ombudsman in 2013, has advised the European Medicines Agency she intends to open a “strategic inquiry” into pre-submission activities between the European Medicines Agency and regulated entities.

O’Reilly is no stranger to controversy, having penned three books that struck a number of nerves, but she also took the government of Ireland to task for what she saw as a problem with transparency. The theme of transparency appears in her July 17 letter to EMA executive director Guido Rasi, which states that pre-submission interactions with EMA staff and industry “may pose some risks,” such as that reviewers at EMA may be influenced by applicants in these interactions. O’Reilly acknowledges that these pre-submission meetings are not necessarily problematic, but said there is risk that these meetings create “in the eyes of the public, at least some perception of bias,” a hazard she asserts “must be managed.”

This risk could be managed by more transparency, O’Reilly continues, stating also that “a preliminary assessment suggests that more could be done in this area” without offering any details related to that preliminary assessment.

O’Reilly inquired as to whether EMA publishes “detailed minutes of pre-submission meetings,” which may strike some in industry as incurring the hazard of loosing the lid on proprietary information. She asked EMA to provide details of such meetings dating back to 2012, and asked for a list of the 10 companies that “met most frequently” with EMA staff in pre-submission meetings.

The inquiry is certain to raise a few hackles, but it’s anyone’s guess as to how far this will go and whether EMA will find this sufficiently distractive to impede the agency’s handling of priority review applications, which are also referenced in O’Reilly’s letter. At the very least, this is a matter that bears watching.

EMA Hits Gadoliniums After FDA Stands Pat

The EMA is no stranger to imposing its will on others, as demonstrated by the fact that it has followed through on a threat to suspend the marketing authorization for three gadolinium-based MRI imaging agents, a move that was not paralleled in a similar FDA review. Among the products up for suspension is one route of administration for Magnevist, a linear gabapentin-based contrast agent (GBCA) manufactured by Bayer Schering Pharma, but the macrocyclic GBCAs escaped relatively unscathed in this review.

The FDA began its investigation into the effects of deposits of GBCAs in human tissues in 2015, but announced in May that it had no data on hand to suggest that retention of these agents in the brain is harmful for most patients. The agency affirmed the notion that linear GBCAs are more the more likely of the two types to be retained in the human body, and said the only known problem is nephrogenic systemic fibrosis, said to occur only in “a small subgroup of patients” who had been diagnosed with kidney failure. The FDA said it would continue to track these patients.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) said earlier in July that it had confirmed “that there is convincing evidence of gadolinium deposition in brain tissues” with the use of gadolinium contrast agents, but while PRAC did not identify specific conditions in connection with deposits in the brain, the committee recommended that EMA suspend the use of Magnevist (gadopentic acid) and two other linear GBCAs, Omniscan (gadodiamide) and Optimark (gadoversetamide).

EMA’s July 21 announcement confirmed the suspension of marketing authorizations for the three linear agents cited by the PRAC, while stating that another linear GBCA, Multihance (gadobenic acid) should be restricted to use in scans of the liver. Another linear GBCA, Primovist (gadoxeticacid), was untouched by the EMA action, although it should be noted that the agency will allow Magnevist to stay on the market for intra-articular use despite the suspension of its use via intravenous administration.

Biosimilars, Biostatisticians, and the New EEU

There are very few days during which the worlds of drugs and medical devices are entirely quiescent, thanks to very active American courts and international regulatory churn. There is some good news in all this, but how good is it?

If you’re in the biosimilars business, the latest news is quite good, indeed.

SCOTUS rules for Sandoz

The U.S. Supreme Court ruled on June 12 that makers of biosimilars do not have to wait six months after the issuance of a biologics license application to begin marketing that product, a development that could bring some less costly biotech drugs to market more quickly and possibly take a bite out of spending on these agents.

In a 9-0 vote, the Court ruled in favor of Sandoz in Sandoz v. Amgen, a case that made a stop at the Court of Appeals for the Federal Circuit, where the outcome was quite different. Sandoz had argued that the terms of the Biologics Price Competition and Innovation Act of 2009 had essentially worked to add half a year of exclusivity to the 12 years already granted by the statute, and by some accounts, Sandoz’s Zarxio is about 15 percent less expensive than Amgen’s Neupogen, a drug for chemotherapy-induced neutropenia.

The news might not change the field dramatically in the near term, given that the FDA has approved only about half a dozen biosimilars to date, but one possible candidate for a quick entry to market is an oncology biosimilar for Avastin, which will undergo an FDA advisory committee review in mid-July. In an ironic twist, Amgen teamed up with Allergan to produce this biosimilar.

Expert witness refuted in Zoloft lawsuit

Pfizer scored a victory in the running lawsuit pertaining to the company’s flagship antidepressant Zoloft, but what may have been the most interesting part of this story is that a court rejected expert testimony relating to allegations that the selective serotonin reuptake inhibitor (SSRI) causes congenital heart defects.

The decision may have brought to a close an effort by more than 300 litigants, which absorbed a second consecutive negative outcome in the U.S. Court of Appeals for the Third Circuit. Both the appeals court and a district court decreed that the expert witness, Nicholas Jewell, a biostatistician at the University of California at Berkeley, had failed to plausibly link the drug to the birth defects. Among the problems with Jewell’s presentation is that he had rejected meta-analyses he had previously cited in a separate lawsuit pertaining to another SSRI.

Whether the plaintiffs will take this lawsuit any further is difficult to forecast, but a footnote on page 10 of the Appeals Court decision remarked that the plaintiffs’ attorneys had conceded that they are “unable to establish general causation” if the courts jettisoned Jewell’s testimony. Summary judgment was granted in favor of Pfizer.

This is not the only multi-district litigation keeping attorneys at Pfizer busy, however. A very active set of lawsuits dealing with proton pump inhibitors and purportedly associated kidney damage would seem to implicate the OTC version of Nexium, marketing rights for which Pfizer picked up five years ago in a deal with AstraZeneca. The U.S. Judicial Panel on Multidistrict Litigation (JPML) declined in January to consolidate these lawsuits, but another motion for consolidation has been filed by attorneys with Seeger Weiss of New York.

Regulations, regulatory agreements on the move

Efforts to ramp up medical device regulatory schemes in outside-U.S. jurisdictions are nothing new, but device makers can add Malaysia and the Eurasian Economic Union (EEU) to the list of national and international entities diving into deeper regulatory waters. The news for device makers is somewhat mixed, but greater clarity alone is sometimes enough to overcome other considerations.

First, Malaysia’s Medical Device Authority has declared that adverse events associated with medical devices will have to be reported to the agency within 30 days. This apparently applies to all devices that are on the Malaysian market, regardless of where the adverse event took place. Any fatalities have to be reported within 10 days, and device makers have a mere 48 hours to advise the agency of any problems that might carry a public health consideration.

The EEU continues to work toward a single market for drugs and devices, a move which if successful would capture the markets of Russia and four other nations for a total 2015 population of nearly 184 million. There are reports that Tehran is interested in a free trade agreement with the EEU, although there is no indication that Iran would take part this new med tech regulatory bloc despite the deepening geopolitical ties with Moscow. Serbia is likewise said to be interested in doing business with the EEU, but it’s not clear whether Belgrade has full-blown membership in mind, either, although the protracted and difficult negotiations for entry into the European Union might strike some as suggestive.

To date, the EEU regulatory regime lacks several critical documents, such as a framework for quality management systems. Registration requirements for this international regulatory system would be phased in over the next four years, however, giving industry a little breathing room for offerings already available in this market.

Liability in EU Market Promises to Grow

Device makers doing business in the U.S. don’t always care for the current state of tort law, but at least they know what to expect. The legal environment in other markets is undergoing some changes that promise to up the ante where financial liability is concerned.

The European Parliament recently voted on the overhaul of device regulations for the European Union, bringing to a close an effort of several years’ duration. As has been previously described at this blog, the notified bodies have their own recent issues with liability in the EU nations, but one of the less conspicuous features of the new Medical Device Regulations is that device makers will have to ensure they can make compensation to all patients who have been harmed by defective medical devices.

The version of the new regulatory framework adopted by the EP includes a requirement that device makers develop “a robust financial mechanism” that will compensate patients who “receive defective products.” There are several factors that go into the calculation of that “robust” mechanism, including the class of the device and the associated risk, but the legislation also points to the size of the manufacturer as a factor. The legislation further stipulates that device makers put themselves in a position to “rapidly and effectively” compensate patients, even when the company has gone out of business.

It requires no reading of tea leaves to realize this provision was sparked at least in part by the silicone gel breast implant scandal, which gained momentum in 2009 when implant rupture rates began to spike. The manufacturer, Poly Implant Prothèse, went bankrupt the following year. The metal-on-metal hip implant problem might also have figured into this provision.

The summary for this legislation is not specific about the nature of this financial mechanism, so it would appear that liability policies will serve in the stead of cash reserves. Whether a manufacturer opts to self-insure or cover this requirement by other means, one thing companies cannot do is leave themselves open to a raft of lawsuits without some sort of plan in place to deal with any claims.

Company beats shareholder suit despite CIA

Minnesota-based Cardiovascular Systems, Inc., persuaded a federal judge to toss out a class-action shareholder lawsuit based on alleged illegal sales tactics, but the suit may be refiled. District Court judge Donovan Frank dismissed the suit (Shoemaker v. Cardiovascular Systems) due to the absence of information specific enough to support the allegations, but Frank left the door open to a reopening of the suit. Cardiovascular had already settled a qui tam lawsuit with the federal government in the amount of $8 million, but the company is also working under a five-year corporate integrity agreement with the Office of Inspector General at the Department of Health and Human Services, which went into effect in June 2016.

PTO to revisit controversial AIA program

Holders of patents who have grown fatigued with the inter partes review process at the U.S. Patent and Trademark Office may be relieved to know the PTO is undertaking a retrospective review of this and other procedures handled by the agency’s Patent Trial and Appeals Board (PTAB). The inter partes review, one of several functions added to the PTO’s to-do list via the America Invents Act (AIA) of 2012, has been widely blasted as doing little to slow down the stream of cases landing at the Court of Appeals for the Federal Circuit, but also for allowing parties with no direct interest in a patent to damage or destroy the patent.

Hedge fund billionaire Kyle Bass has not been uniformly successful with the inter partes process, losing a challenge to the patent for Shire’s Lialda (mesalimine) late in 2016, but Bass has managed to invalidate a number of important patents via the process. PTO director Michelle Lee has instructed PTO staffers to review issues such as multiple petitions, motions to amend, and claims construction. The PTO announcement did not identify a date by which the review would be complete, however.

Life Science News Roundup, 2/14

  • Mexico Proposes Changes to Medical Device Regulations in 2018 – Emergo Group
  • GSK on America First: US Will Not Be Able to Own Every Part of Supply Chain – In-Pharma Technologist
  • Digital Health Startups Should Raise Awareness of Health Issues, Not Flaunt Tech – Medcity News
  • ATA Releases State-by-State “Report Card” of Telemedicine Policies; Texas Finds Compromise – MobiHealthNews