miércoles, 1 de junio de 2016

Transparency Info for Certified Health IT; ONC Annual Meeting Day 2

Transparency Info for Certified Health IT; ONC Annual Meeting Day 2

Today, the Office of the National Coordinator for Health Information Technology (ONC) began listing more detailed and easier-to-understand information about certified health information technology (health IT). Via an upgraded website, purchasers of health IT can access information about costs and limitations they may encounter when implementing and using certified health IT products. The disclosure of this information is required by ONC’s recent 2015 Edition final rule, which includes several provisions to increase transparency and accountability to help purchasers better compare and select products that meet their needs.

Visit HealthIT.gov/Transparency

Today is the second day of the 2016 ONC Annual Meeting: Committed to Better Health through IT at the Walter E. Washington Convention Center in Washington, D.C. On-site registration is available today and tomorrow. Also, follow the action on Twitter with#ONC2016. Here’s what’s coming up today:

Time	Session
WEDNESDAY, JUNE 1, 2016 \| Shared Learning Day \| 9:00 AM – 5:00 PM WALTER E. WASHINGTON CONVENTION CENTER – FLOOR 2
8:30 AM – 9:00 AM	Registration and Check-In
9:00 AM – 10:30 AM	Breakout Sessions
Empowering Precision Medicine through Health IT (Room 202A) Provider Directory Workshop: A Vision for Future Efforts (Room 202B) Hospital Interoperability: Latest National Findings and Reflections on Future Progress(209A/B) Building Data Infrastructure for Research through Patient-Centered Outcome Research (PCOR) (Room 203A/B) The Journey from Current State to Ideal State: Scaling Alternative Payment Models(Room 204A/B) Advancing Health IT Alignment Across Medicaid (Room 208A/B)
10:30 AM – 10:45 AM	Networking Break
10:45 AM – 12:15 PM	Breakout Sessions
The Challenges of Zika: A Health IT Response (Room 202A) Measuring Interoperability Progress: The Roadmap, MACRA, and Beyond (Room 202B) Computable Privacy and the Basic Choice of Opting-In and Opting-Out of Electronic Exchange (Room 209A/B) Price Transparency Showcase: Advances in Accessing Prescription Co-Pay Information at the Point of Care (Room 203A/B) SIM: Advancing Health IT and Value-Based Payment at the State Level (Room 204A/B) Promoting Community Collaboration through Real World Standards Adoption and Implementation (Room 208A/B)
12:15 PM – 1:45 PM	Lunch on Your Own
1:45 PM – 3:15 PM	Breakout Sessions
Cybersecurity: "Beware the Ransom" and other Helpful Cyber Hygiene Tips (Room 202A) Immunizations and Interoperability: ONC Pilot Projects (Room 202B) Telehealth and Delivery System Reform: Advancing Person-Centered Care (Room 209A/B) Grants Management 101: Maintaining Your ONC Award (Room 203A/B) Inside MACRA's Quality Payment Program (Room 204A/B) Identifying, Assessing, and Determining Best Available Standards (Room 208A/B)
3:15 PM – 3:30 PM	Networking Break
3:30 PM – 5:00 PM	Breakout Sessions
The Prescription Opioid and Heroin Crisis: Using Health IT to Combat the Epidemic(Room 202A) Corrections to Community: Transition and Integration of Health from the Justice System (Room 202B) Behavioral Health: Adoption, Information Exchange, and Integration Across Settings and Provider Types (Room 209A/B) Federal Health Architecture: The Federal Advantage (Room 203A/B) CPC+ and SIM: Update on Multipayer Models (Room 204A/B) Community Based Services: Integration and Opportunities to Promote Accessibility and Usability (Room 208A/B)

View the full agenda on HealthIT.gov

Summary of AHRQ-Supported Health Literacy and Palliative Care Workshop Now Available

Download free Summary of Health Literacy and Palliative Care Workshop

A summary of the July 9, 2016 AHRQ-supported Health Literacy and Palliative Care Workshop is now available from the National Academies of Sciences, Engineering, and Medicine. The 1-day public workshop, convened by the Roundtable on Health Literacy, explored the relationship between palliative care and health literacy, and the importance of health literate communication in providing high-quality delivery of palliative care.

You can access workshop materials, including videos of presentations and slides sets, at:http://nationalacademies.org/hmd/activities/publichealth/healthliteracy/2015-jul-09.aspx.

You can access the workshop summary at: http://www.nationalacademies.org/hmd/Reports/2016/Health-Literacy-and-Palliative-Care-Workshop-Summary.aspx.

To learn more about AHRQ health literacy resources, go to: http://www.ahrq.gov/health-care-information/topics/topic-health-literacy.html.

To learn more about palliative care research at AHRQ, go to: http://www.ahrq.gov/health-care-information/topics/topic-palliative-care.html.

Announcing the CDER SBIA REdI Pharmaceutical Quality Symposium - July 20/21- Registration NOW OPEN!

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

CDER SBIA invites you to join us for this two-day in-depth exploration into the world of pharmaceutical quality. Interact with FDA’s subject matter experts from our Office of Pharmaceutical Quality (OPQ) as we address topics such as:

Microbial Controls * Manufacturing Process * Facilities Assessment * Method Validation

* Conference Information *

* Register Here *

- Available for attendance in-person or virtually online -

Pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification uponfull completion

Hotel Block at discounted rate available until June 22nd

There is no cost to register. However, we ask that you honor your registration commitment.

Be sure to take advantage of this opportunity!

Registration is required for both in-person and online attendance.

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.

Email: CDERSBIA@fda.hhs.gov
Phone: 1-866-405-5367
Phone: (301) 796-6707
Website: http://www.fda.gov/cdersbia

U.S. Food & Drug Administration (FDA) FDA/CFSAN Cosmetics News Update

FDA’s Cosmetics News. This information has been updated:

Microbiological Methods for Cosmetics from FDA’s Biological Analytical Manual

FDA Law Blog: It’s Finally Here! FDA’s VASCEPA Exclusivity Determination on Remand: NCE Exclusivity Granted!

It’s Finally Here! FDA’s VASCEPA Exclusivity Determination on Remand: NCE Exclusivity Granted!

Posted: 31 May 2016 01:05 PM PDT

By Kurt R. Karst –

It’s been just over a year – May 28, 2015 – since Judge Randolph D. Moss of the U.S. District Court for the District of Columbia handed down his 40-page Opinion in a lawsuit lodged by Amarin Pharmaceuticals Ireland Limited (“Amarin”) against FDA challenging the Agency’s February 21, 2014 Exclusivity Determination that Amarin’s VASCEPA (icosapent ethyl) Capsules, 1 gram, which FDA approved on July 26, 2012 under NDA 202057, is not eligible for 5-year New Chemical Entity (“NCE”) exclusivity. Our year-long patient waiting came to an end on May 31, 2016 when FDA finally issued a new Exclusivity Determination concluding that VASCEPA is eligible for (i.e., granted) 5-year NCE exclusivity. The 16-page Exclusivity Determination, announced by Amarin, is the latest – and perhaps the last – chapter in an exclusivity saga that started years ago. And it comes on the heels of the so-called “NCE-1” date when an ANDA for a generic version of a drug product granted NCE exclusivity and containing a Paragraph IV certification can be submitted to FDA: July 26, 2016.

As readers of this blog know, in May 2015, Judge Moss ruled for Amarin, granting the company’s Motion for Summary Judgment and denying FDA’s Motion for Summary Judgment. In setting aside FDA’s exclusivity decision, Judge Moss wrote:

[FDA’s] ultimate conclusion that Vascepa, a drug “no active ingredient of which . . . has been approved” in a previous NDA, was not entitled to exclusivity, is contrary to the statute’s plain meaning. Rather than explaining this discrepancy, the administrative decision only adds to the problem by emphasizing the divergence between the Agency’s regulatory inquiry and the statutory requirement. Whether the problems with the FDA’s decision are characterized as failures under Chevron step one, step two, or the APA’s requirement of reasoned decision-making, the Agency’s decision must be set aside.

Judge Moss remanded the matter to FDA for further proceedings consistent with his Opinion.

We won’t repeat all of the facts and circumstances – and the twists and turns – that led up to FDA’s May 31, 2016 Exclusivity Determination. You can refer to our previous posts for that – see here and here. But in a nutshell, FDA’s rationale for denying NCE exclusivity was that eicosapentaenoic acid (“EPA”), “the single active moiety in Vascepa, was also an active moiety contained in another, previously approved drug, Lovaza (omega-3-acid ethyl esters) Capsules (Lovaza),” that FDA approved on November 10, 2004 under NDA 021654. Specifically, in denying NCE exclusivity for VASCEPA, FDA rejected the “one-to-one” framework and relationship between active ingredient and active moiety traditionally applied when deciphering the active moiety in a drug product. Instead, for naturally derived mixtures, such as LOVAZA, FDA applied a “one-to-many” approach. According to FDA, “[i]n cases where at least part of the mixture is well characterized and some components of the mixture that are consistently present and active are identifiable or have been identified, . . . [t]he approach that is the most consistent with the relevant definitions, facts, and policies present in this case is one in which the entire mixture is the single active ingredient, but that active ingredient may contain more than one component active moiety.” Judge Moss flatly rejected this “one-to-many” approach and FDA’s rationale for it as inconsistent with the statute.

Going back to the drawing board with Judge Moss’ decision in hand, FDA says that the Agency “reevaluated whether the ‘one-to-many’ or the ‘one-to-one’ framework should be applied to Lovaza to determine whether EPA is an active moiety previously approved in Lovaza,” and thus, whether or not VASCEPA contains an NCE and should be granted 5-year exclusivity. Upon reevaluation, and given “[m]ultiple factors unique to this matter,” FDA landed on adopting the “one-to-one” framework in this case, and ultimately concludes that EPA was not previously approved. FDA lays out those factors in the May 31, 2016 Exclusivity Determination:

First and foremost, the Agency took into consideration the Court’s Opinion, and, in particular, the Court’s finding that, in light of FDA’s previous decision that the entire mixture is the active ingredient of Lovaza, the application of FDA's exclusivity regulations to Lovaza under the “one-to-many” framework was inconsistent with the statutory language.

Second, the Agency considered its prior active ingredient determination for Lovaza and the reasons underlying it. At the time of approval, FDA determined that the active ingredient of Lovaza was the entire mixture. Also at the time of approval, FDA explicitly rejected the suggestion from Lovaza’s sponsor that Lovaza’s established name should consist of the names “EPAee” and “DHAee,” determining instead that the name “omea-3-acid ethyl esters” would be suitable because it “was designed to correspond to the mixture.”

In addition, in its Lovaza Strength Citizen Petition Response, FDA reaffirmed its conclusion that Lovaza's active ingredient is the entire fish oil mixture.

Third, FDA reviewed previous Agency 5-year NCE exclusivity decisions in the context of naturally derived mixtures and notes again that at least some of those decisions are consistent with the “one-to-one” framework. As the Agency acknowledged in its initial Vascepa exclusivity determination, “the few relevant prior Agency statements and prior actions where FDA considered 5-year NCE exclusivity matters in the context of naturally derived mixtures have not necessarily resulted in consistent outcomes.” Some of those decisions, however, suggest that the Agency could consider the entire mixture to be both the active ingredient and the active moiety for Lovaza, as it did in the exclusivity determinations for the lung surfactants InfaSurf and Curosurf and for products containing pancrelipase and hyaluronidase.

Fourth, the Agency considered the lack of guidance describing how FDA makes exclusivity determinations for naturally derived mixtures. Prior to the issuance of the Vascepa exclusivity determination, there was no explicitly defined framework for identifying active moieties in the context of naturally derived mixtures for purposes of 5-year NCE exclusivity, nor could one easily be gleaned from the applicable statute, regulations, and precedent. As discussed above, the statute and regulations do not expressly address 5-year NCE exclusivity in the context of naturally derived mixtures. In fact, the prior Agency statements and actions regarding this matter were difficult to reconcile. Although guidance is not required before FDA can act, FDA believes the lack of guidance and diversity of practice also counsels in favor of applying the “one-to-one” framework on remand.

Lastly, the Agency considered whether any of the reasons it had provided for declining to adopt the “one-to-one” framework when it previously considered the active moiety for Lovaza bars adopting the “one-to-one” framework for Lovaza now. . . . [J]ust as the Court recognized that FDA is free to determine whether any particular naturally derived mixture is better understood as containing one or multiple active ingredients, so too the Agency believes it has regulatory and scientific discretion to determine whether any particular naturally derived mixture can be described as containing one or multiple active moieties. Accordingly, as explained in this letter, the Agency has determined, in order to bring the Agency’s decision in harmony with the Court’s Opinion, that the active moiety of Lovaza, a partially characterized mixture, is the entire mixture.

FDA takes great pains to emphasize that the Agency’s May 31, 2016 Exclusivity Determination applies only in the case of LOVAZA/VASCEPA, noting that the ruling is made “under the narrow circumstances of this case” and given the “unique” factors of the matter. Despite FDA’s best efforts, however, creative lawyers will find ways to use Judge Moss’ decision to their benefit when arguing for (or perhaps against) a future FDA exclusivity determination.

Los wearables y el Internet de las cosas multiplicarán su crecimiento este año

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Cumbre de expertos en tecnología digital

Los wearables y el Internet de las cosas multiplicarán su crecimiento este año

· 15.000 millones de objetos están conectados a Internet

· Ya se venden más relojes inteligentes que pulseras wearables

Madrid, 1 de junio de 2016. El mercado de wearables (dispositivos vestibles) y de Internet de las cosas (IoT) se incrementará una media del 18% en 2016, aunque multiplicará su crecimiento en los próximos cinco años, según los responsables de la III Conferencia Wearable Technology & Internet of Things. Este evento, organizado por Zerintia Technologies, se celebra en el ICEMD-Instituto de Economía Digital de ESIC este viernes 2 de junio. “Los wearables y el Internet de las cosas han pasado de ser una moda a una tendencia en la economía. Casi sin darnos cuenta hemos incorporado a nuestras vidas dispositivos electrónicos con sensores con los que interactuamos y que comparten información con otros dispositivos de manera autónoma. La consecuencia es una mejora de la eficiencia en el trabajo y una mejor calidad de vida, tanto en el ámbito urbano como doméstico”, destaca Pedro Diezma, CEO de Zerintia Technologies.

Este año se venderán 274 millones de wearables en todo el mundo, según la consultora Gartner, lo que supone un 18% de incremento con respecto al año pasado, aunque en el sector de los relojes inteligentes o smartwatches, ese incremento llegará a ser de más del doble en dos años. La consultora CCS Insight calcula que en 2020 la mitad del mercado de wearables sea de smartwatches. La irrupción de Apple es la causa principal de este crecimiento, según los analistas, y las ventas de este tipo de relojes ya supera el de las pulseras (smartbands), centradas en el ejercicio físico.

En cuanto al llamado Internet de las cosas (IoT), o transmisión de información entre objetos a través de la Red, el mercado es aún más pujante. Según Intel, existen ya 15.000 millones de objetos conectados a Internet y la facturación pasará de los 638 mil millones de euros actuales a 1,18 billones en 2019. “En pocos años interactuaremos cada día con miles de objetos conectados a Internet y ellos entre sí. Eso supone una transformación radical en el mundo de la empresa y del ocio”, señala Diezma.

Realidad virtual

En la conferencia participan las principales compañías internacionales y españolas que están utilizando wearables e IoT para mejorar su eficiencia y fidelizar clientes, como Microsoft, Intel, BBVA, Telefónica, Airbus, LG, Philips y Mahou. También habrá un apartado dedicado a la Realidad Virtual, a la Inteligencia Artificial y el Big Data y la tecnología complementarias para proyectos IoT (como impresión 3D y drones). Asimismo, habrá talleres prácticos para probar gafas de Realidad Virtual e integrar loT en la empresa.

En el ámbito de la salud, Carlos Mateos, director de la agencia COM Salud y vicepresidente de la Asociación de Investigadores en eSalud, hablará de la importancia de desarrollar una estrategia de comunicación para que la tecnología en salud se conozca y utilice. “Existen muchos dispositivos electrónicos en el mercado que aseguran ayudar a la salud y el bienestar pero la mayoría acaban siendo abandonados o no pasan de un prototipo porque nunca se han dado a conocer. Es necesario validar estos aparatos y servicios científicamente, que los pacientes puedan compartir la información que proporcionan con los profesionales sanitarios y difundir sus propiedades”, explica Carlos Mateos.

Los wearables en forma de pulseras han sido los precursores del mercado. Su uso es sobre todo en el ámbito del deporte. Sin embargo, en los últimos años han aparecido otros objetos vestibles como gafas (smartglasses), relojes, camisetas, zapatillas e incluso tatuajes electrónicos. Su aplicación en la salud se extiende desde la prevención hasta el control de pacientes crónicos, añade Mateos.

Más información: www.wearablespain.com