jueves, 31 de agosto de 2017

Texas Acts to Facilitate Continued Access to Daily HIV Medication for Texans Living With HIV Affected by Hurricane Harvey | HIV.gov

Texas Acts to Facilitate Continued Access to Daily HIV Medication for Texans Living With HIV Affected by Hurricane Harvey | HIV.gov

Hurricane Harvey & Access to HIV Medications

Texas Acts to Facilitate Continued Access to Daily HIV Medication for Texans Living With HIV Affected by Hurricane Harvey

August 30, 2017 - HIV.gov Blog

TOPICS: ADAP, Emergency Prep, PLWHA, Ryan White, Treatment
Hurricane Harvey and its aftermath have disrupted the lives of millions of people, including people living with HIV. The Texas HIV Medication Program (THMP), the state’s Ryan White HIV/AIDS Program Part B AIDS Drug Assistance Program (ADAP), has implemented measures to help facilitate continued access to daily HIV medication for those impacted by Hurricane Harvey... [READ MORE]

CDER New August 31, 2017

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What's New on the FDA Drugs Site

August 30, 2017

FDA Seeking Comments on Draft Guidance: Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices

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Today, the Food and Drug Administration (FDA) released a draft guidance document, "Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices." This draft guidance describes FDA’s proposed recommendations for complying with the performance standard requirements in 21 CFR 1050.10 related to ultrasonic diathermy devices when a manufacturer has otherwise complied with certain International Electrotechnical Commission (IEC) standards.  Because conformance to certain IEC standards identified in this draft guidance adequately addresses the technical concerns intended to be addressed by the performance standard requirements, once this guidance is finalized, FDA does not intend to consider whether firms who provide a declaration of conformity and indicate conformance to applicable IEC standards also comply with 21 CFR 1050.10.
In addition, this draft guidance document proposes recommendations for information to provide in 510(k) submissions for these ultrasonic diathermy devices.
Comments to this draft guidance should be submitted either electronically or in writing within 60 days of publication in the FEDERAL REGISTER.  Comments can be submitted to http://www.regulations.gov/ under Docket No. FDA-2017-D-4764.

Thank you,
Food and Drug Administration
Center for Devices and Radiological Health

CDRH Industry: FDA Releases Final Guidance on Procedures for Meetings of the Medical Devices Advisory Committee

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Today, the FDA released the final guidance document "Procedures for Meetings of the Medical Devices Advisory Committee." This final guidance clarifies the procedures, processes and participant roles for advisory committee meetings.
The final guidance includes:
  • general information about the topics and types of panel meetings, including premarket submission and regulatory issues meetings;
  • more information about the process for premarket submission panel meetings, including briefing materials, timing, updates to communication procedures, and when a panel by teleconference may be appropriate;
  • clarification on the conduct of panel meetings, including industry and Center for Devices and Radiological Health (CDRH) presentations, and voting procedures;
  • information about post meeting activities, such as posting a summary of the meeting; and
  • updates that reflect statutory changes from the 21st Century Cures Act.
If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, or via phone at 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health

FDA Law Blog: Trailblazer Amarin Takes on a New Fight with ITC Complaint Against Synthetic Omega-3 Oil Manufacturers and Dietary Supplement Distributors

FDA Law Blog: Trailblazer Amarin Takes on a New Fight with ITC Complaint Against Synthetic Omega-3 Oil Manufacturers and Dietary Supplement Distributors

Posted: 30 Aug 2017 06:59 PM PDT
By Kurt R. Karst –

Whether in the context of asserting First Amendment protection for a pharmaceutical manufacturer’s off-label promotion of an otherwise approved drug (see our previous post here), or successfully challenging FDA’s denial of New Chemical Entity exclusivity VASCEPA (icosapent ethyl) Capsules, 1 gram, (NDA 202057) (see our previous post here), that then led to yet another first, the dismissal of related ANDA patent litigation (see our previous post here), Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Ltd. (collectively “Amarin”) have broken significant new ground in food and drug law over the past several years with victory after victory in court against FDA and others.  Now, Amarin aligns itself closely to the FDC Act and years of related FDA interpretations as the company seeks to break even more new ground by turning its sights on a new target: synthetic omega-3 oil manufacturers and dietary supplement distributors; and in a new forum: the United States International Trade Commission (“ITC”).  Without saying as much, Amarin characterizes these players as “cheaters,” and the company is seeking to shut them out of the omega-3 game with respect to products that resemble VASCEPA.  Although derived from fish, VASCEPA is not fish oil.  It is 1 gram of the ethyl ester form of the omega-3 Eicosapentaenoic Acid (“EPA”) that is  manufactured synthetically through chemical alteration.

In a 110-page Complaint  filed with the ITC on August 30, 2017 (along with a Brief on Jurisdiction and a Public Interest Statement), Amarin requests that the ITC “commence an investigation into the unlawful importation or sale in the United States of synthetically produced omega-3 products that are predominantly comprised of EPA in either ethyl ester (‘EE’) or re-esterified (‘rTG’) form and are falsely labeled, and/or promoted for use as, or in ‘dietary supplements’. . .” According to Amarin, “[t]hese products are cloaked as ‘dietary supplements’ but are actually unapproved ‘new drugs’ under the Federal Food, Drug and Cosmetic Act (‘FDCA’).”  Furthermore, says Amarin, “[t]he false labeling or promotion of these products constitutes an unfair act and/or unfair method of competition under Section 337 [of the Tariff Act of 1930, as amended, 19 U.S.C. § 1337] because, among other things, these acts violate Section 43(a) of the Lanham Act, 15 U.S.C. § 1125(a), and the standards established by the FDCA.”  (For those folks not familiar with the Tariff Act, Section 337 prohibits unfair acts and unfair methods of competition involving imports, and provides that the importation or sale of infringing goods in the United States is unlawful.)

Essentially, Amarin seeks to prevent import into the United States and the further sale of synthetic concentrated omega-3 products that contain predominantly EPA. But, to be clear, this is not a case against common fish oil, which comprises the large majority of the omega-3 dietary supplement market.  Instead, it is a case against only those products – which Amarin refers to as “Synthetically Produced Omega-3 Products” in the company’s ITC filings – that have synthetically modified oil in EE or rTG form that contain more EPA than Docosahexaenoic Acid  (“DHA”) (another omega-3) or any other component.  “An exclusion order in this case will not raise any public health, safety, or welfare concerns.  Rather, removal of the purported ‘dietary supplements’ will further the public interest because those products are actually drugs that evade FDA regulation,” says Amarin in the company’s Public Interest Statement.  “Absent such an exclusion order, Proposed Respondents will continue to operate outside of the FDCA’s drug regime, which was established by Congress to protect and promote the public health.  21 U.S.C. § 393(b).  These activities will undermine incentives to invest in drug development, . . . and they may more immediately affect the public health.”

With respect to the Lanham Act, Amarin alleges that the importation and sale of the Synthetically Produced Omega-3 Products identified in the Complaint, as well as their “false or misleading representations about those products,” constitute unfair acts or unfair methods of competition in violation of the Lanham Act and the federal common law of unfair competition. For starters, Amarin alleges that distributors of the identified Synthetically Produced Omega-3 Products are making literally false statements about their products insofar as their labeling asserts that the products are “dietary supplements”:

The definition of “dietary supplement” in the FDCA applies only to products that, among other things, bear or contain one or more of the following “dietary ingredients”: “(A) a vitamin, (B) a mineral, (C) an herb or other botanical, (D) an amino acid, (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E).” 21 U.S.C. § 321(ff)(1). Products marketed with ingredients that do not fall within the categories of “dietary ingredients” listed in Section 201(ff)(1) of the FDCA, 21 U.S.C. § 321(ff)(1), cannot be marketed as, or for use in, “dietary supplements.” See id.

The Synthetically Produced Omega-3 Products are not “dietary supplements” because E-EPA, rTG-EPA, E-OM3, and rTG-OM3 do not fall into any of the categories of “dietary ingredients” under the Section 201(ff)(1) of the FDCA.
Instead, Amarin says that all of the Synthetically Produced Omega-3 Products meet the definition of “drug” in the FDC Act . . . and that they’re also unapproved “new drugs,” “because they are not generally recognized by qualified experts as safe and effective for their intended uses.”  As such, the importation and sale of the identified Synthetically Produced Omega-3 Products “constitute unfair acts or unfair methods of competition under Section 337 based upon the standards set forth in the FDCA.”

Of particular note is Amarin’s attempt to leverage and seek to extend the U.S. Supreme Court’s 2014 ruling in POM Wonderful LLC v. Coca-Cola.  As we previously posted, the Supreme Court held in POM Wonderful that the FDC Act does not preclude a private party from bringing a Lanham Act claim in U.S. District Court challenging a misleading food label that is regulated under the FDC Act.

Amarin applies the POM Wonderful decision for the first time at the ITC, and seeks to extend the POM Wonderful notion of “regulatory synergies” achieved from competition-focused lawsuits that have a basis in a regulatory violation.  “POM Wonderfulis directly on point,” says Amarin in the company’s Brief on Jurisdiction.

The Synthetically Produced Omega-3 Products are labeled as “dietary supplements,” or are intended for use in “dietary supplements,” such that FDA and potential customers are tricked into believing that these products in fact meet the definition of “dietary supplement” in the FDCA, 21 U.S.C. § 321(ff), even though that is not the case. Like the beverage at issue in POM Wonderful, the purported “dietary supplements” at issue here are sold without FDA premarket review.

“Dietary supplements,” like beverages, are in fact a type of “food” under the FDCA. See id. § 321(f), (ff).  As with beverages, to police purported “dietary supplements,” FDA has to rely on enforcement actions, warning letters, and other measures.  Because of limited resources, however, the agency cannot detect every violation nor, as the Supreme Court observed in POM Wonderful, can it pursue every violation it detects. . . .

Thus, as in POM Wonderful, the regulatory synergies between the Lanham Act and the FDCA are important here – if a federal district court were to preclude the Lanham Act claims over dietary supplements, commercial interests and, indirectly, the “public at large” would be unprotected.
Amarin’s Complaint may very well be the start of a Battle Royale between the pharmaceutical and dietary supplement industries. It could be the food and drug law version of Floyd Mayweather versus Conor McGregor. Right now we’re at the weigh-in.   We’ll be closely watching this case as it progresses through the rounds.  Will Amarin score another knock-out?

CDRH New Update

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Date: August 31, 2017

The following new item was added to the CDRH web pages on August 30, 2017. Previous items can be found on the CDRHNew Page.

Waiting women |August 31, 2017|MercatorNet |

Waiting women

|August 31, 2017|MercatorNet 

Waiting women

If a woman has to wait for an abortion, there is an outcry. Think how that affects women waiting for a child.
Andrea Mrozek | Aug 31 2017 | comment 

There are the women whose waiting doesn’t matter. And then there are the women whose waiting is especially terrible and reported on at regular intervals. 
The Canadian Press reported on August 15 that a 29-year-old whose birth control failed got the abortion she wanted. Except it wasn’t quite fast enough. She waited too long for her abortion, she says. She waited two months. This was reported in major media outlets across the country. “Abortion access in Nova Scotia among worst in Canada, advocates say,” read the headline.
Women always get their abortions—so far not one story of an abortion denied—but the agony of the waiting: that’s the story.
There are other women, waiting. They are waiting for pregnancies. Statistically, women are trying at older ages to have children. Time is not on their side. They still know of women who managed to get pregnant at 42 or 45, and it keeps them going. They take vitamins. They try acupuncture. They stimulate ovulation. They take hormonal supplements. They are poked and prodded. They change their diets. And they wait.
Merely two months of waiting would be a dream come true.
For some women, infertility is painful and every pregnancy announcement is like a stab in the side. 
Abortion announcements, on the other hand, are much, much worse. A much-coveted conception, cast aside. One woman’s treasure is another woman’s imposition. Or disposition. Don’t you know, it’s all about personal choice? Don’t ask why, because any reason is a good reason. And don’t let those women wait. They can’t wait. The waiting makes them (so they say) feel shame. Not the abortion. The waiting.
Of course, waiting too long for an abortion has the terrible complication of delivering a baby.  Early in the first trimester, one can more easily be deceived into wondering whether that is actually true. But every woman knows the end point is a baby and that is why abortions must be done quickly. At 12 weeks, for wanted pregnancies, eager mothers learn how the fingers of their babies are opening and closing, how the baby’s mouth makes sucking movements.
It’s better to get an abortion before the fingers start opening and closing. Before you know that the 12-week-old is making sucking movements.
When the Canadian Press reported that Nova Scotia is “among the worst in Canada, advocates say, for abortion access,” there should have been heavier emphasis on “advocates say.”
For advocates, there’s no abortion that shouldn’t be done sooner. Sometimes they get it wrong, publicly, as in the recent case in Newfoundland where a 12-year-old got a quick abortion and then another. It turns out her stepfather was abusing her. But there was no time to ask.
Advocates for abortion in Nova Scotia, it also turns out, have no data—something we learn in the fourth to last paragraph of the story: “Nova Scotia does not appear to keep statistics on how long it takes women to obtain an abortion after a referral.”
Still, the story sailed through under the headline about “worst in Canada” wait times for abortion. No editor batted an eye. A woman said she waited. And these women must not wait.  
What abortion advocates want is to have their cake and eat it too. Abortion is such a hard decision, they say. Not at all easy, they say. Meanwhile, here, they want no time allotted to making that tough decision. No reflection. No waiting. This particular hard decision must be made quickly.
Melanie Mackenzie’s story was the lead for the Canadian Press article: “It was the worst two months of my life. The whole thing felt like a punishment,” she said.
That feeling of punishment is something some infertile women, feel too. Did I do something wrong? Why won’t pregnancy happen for me?
For women waiting for pregnancy, if they’ve had abortions in the past, that waiting is all the more a punishment.
It shouldn’t be. But one can forgive them for feeling that way. 
Women get pregnant and they get abortions. Women wait for conceptions that they then track diligently through all gestational stages, holding their breath till a baby is born.
When women are waiting for pregnancy, they’re not allowed to say it hurts when reporters conjure up headlines about abortions that did happen, just not quite fast enough.
So many women in Canada waiting. But only one group has a loud lobby who will push non-stories to reporters.
The rest? They can wait.
Andrea Mrozek is Program Director of Cardus Family. Prior to joining Cardus, she was the Executive Director at the Institute of Marriage and Family Canada. This article is republished with permission from Convivium, the Cardus faith and community blog.


The front page of the New Zealand Herald today had a teaser with a picture of of Princess Diana and the question, "Where were you when you heard the news?" -- of her death. Strangely enough I do remember: I arrived at a friend's birthday party where everyone was talking about it.

The sudden death of the beautiful but tragic princess and mother certainly reverberated around the world, but in Britain the tide of sentiment turned against the Royal Family in a way that no-one could have predicted.

The British conservative pundit Peter Hitchens (brother of the late, famous Christopher Hitchens) considers that the episode permanently weakened the monarchy, at the same time manifesting the "collapse of Protestant Christianity" and the "Christian married family." in Britain. He's a pessimist, but not without reason, perhaps. Read Laura Perrins' interview with him.

Carolyn Moynihan

Deputy Editor,
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Waiting women
By Andrea Mrozek
If a woman has to wait for an abortion, there is an outcry. Think how that affects women waiting for a child.
Read the full article
Twenty years after Diana’s death, the state of Britain and its monarchy
By Laura Perrins
The public mourning for the 'People's Princess' manifested the collapse of traditional institutions.
Read the full article
The benefits of being an only child
By Marcus Roberts
But are we missing some obvious downsides?
Read the full article
The upside of a crisis
By Sheila Liaugminas
It took Hurricane Harvey to do what no movement could, in a few days
Read the full article
How beauty is the true goal of leadership
By Andre van Heerden
A chance conversation sparks new insights into a vexed question.
Read the full article
Think. For. Yourself.
By Michael Cook
Independent thinking is being penalised at many universities
Read the full article
Preparing for the rebuilding of Western civilisation
By Patrick F. Fagan
It starts with the rebuilding of our families.
Read the full article
Is fake news a fake problem?
By Michael Cook
There's very little proof that 'fake news' influenced the outcome of the 2016 US election
Read the full article
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miércoles, 30 de agosto de 2017

HCUP Overview Webinars on 9/6 and 9/13 - Registration Now Open

HCUP Overview Webinars on 9/6 and 9/13 - Registration Now Open

Register for Webinars to Learn about HCUP:

September 6 - Overview of HCUP Databases
September 13 - Overview of HCUP Products and Tools

The Agency for Healthcare Research and Quality (AHRQ) is offering a two-part webinar series on the Healthcare Cost and Utilization Project (HCUP)’s research-enhancing databases, products, and tools.

Overview of the HCUP Databases
Summary: This one-hour session will introduce health services and policy researchers to the HCUP databases and related resources through a general overview of HCUP’s databases.
When: Wednesday, September 6, 2017 at 2:00 – 3:00 pm ET.

Overview of the HCUP Products and Tools
Summary: This one-hour session will introduce health services and policy researchers to the HCUP products and tools, with a particular emphasis on HCUPnet, the free online data query system.
When: Wednesday, September 13, 2017 at 2:00 – 3:00 pm ET.

Registration is Now Open. Registration details are available on the HCUP User Support Web site