Judge Reverses Age Restrictions On Morning-After Contraceptives.

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US District Judge Edward Korman's decision Friday to reverse age restrictions on over-the-counter access to emergency contraceptive products was covered by all three broadcast networks, two which led with the story. Most of the media coverage noted Judge Edward Korman's frustrations with Health and Human Services Secretary Kathleen Sebelius having overruled a 2011 Food and Drug Administration recommendation to allow emergency contraception to be sold OTC to all ages; and several outlets noted that Korman, who presides over the District Court of Eastern New York, also placed some of the blame on the FDA for restricting access to the morning-after products in the past.

        The CBS Evening News (4/5, lead story, 3:10, Pelley) opened by reporting, "Anyone of any age may soon be able to walk into a drugstore and buy the morning-after pill. ... Throwing the dictionary at the Administration, Judge Edward Korman called the rule 'arbitrary, capricious, unreasonable and obviously political.'" CBS (Cordes) added that at the time of her 2011 decision, HHS Secretary Kathleen Sebelius "had argued younger girls might not understand the drug's labeling, leading to misuse."

        NBC Nightly News (4/5, lead story, 2:50, Williams) opened by saying, "This is a medical issue. It's a social issue. It's a moral issue for a lot of people." NBC (Gosk) added, "Barring an appeal, the legal battle over the drug and who should be allowed to buy it is over." On ABC World News (4/5, story 3, 2:15, Muir), Amy Robach reported, "Girls can soon be able buy the morning-after pill, 'Plan B', as easily as a bottle of aspirin."

        The AP (4/5) reported President Obama "had supported the 2011 decision setting age limits, and White House spokesman Jay Carney said Friday the president hasn't changed his position. 'He believes it was the right common-sense approach to this issue,'" Carney said.

        In a front-page story, the New York Times (4/6, A1, Belluck, Subscription Publication) reported that Judge Korman's decision "counteracts an unprecedented move" in 2011, by Secretary Sebelius, who "overruled" an FDA recommendation. In 2011, FDA Commissioner, Dr. Margaret A. Hamburg released a statement "saying that after rigorous study, it was safe to sell Plan B One-Step [levonorgestrel] over the counter for all ages." Moreover, the Times pointed out that scientists, "including those at the FDA, have been recommending unrestricted access for years, as have major medical groups, including the American Medical Association, the American Congress of Obstetricians and Gynecologists and the American Academy of Pediatrics."

        ABC News (4/6, Lupkin) on its website pointed out that Plan B, which prevents a "fertilized egg from attaching itself to the uterine wall," has been sold OTC in "China since 1998, and a study published in 2011 in the journal Human Reproduction involving 2,521 women found no adverse side effects. The most common side effects were vaginal bleeding and headaches."

        USA Today (4/5, Stanglin) reported that in his "59-page ruling," Judge Korman "said that Sebelius, in overruling the FDA, had forced the agency to 'to ride roughshod over the policies and practices that it has consistently applied in considering applications for switches in drug status to over-the-counter availability.'" Korman also "noted that the FDA itself had engaged in its own foot-dragging over the years, dating from the Bush administration, when the plaintiffs first began trying to get it to rule on Plan B more than 12 years ago. 'The FDA has engaged in intolerable delays in processing the petition,' he wrote."

        According to the Washington Post (4/6, Kliff, Dennis), the FDA initially, "approved Plan B as a prescription emergency contraceptive in 1999" and in 2003, its manufacturer asked the agency permit OTC sales of the drug but the "FDA rejected that request, citing a lack of data on how the drug affected young teenagers." However, two "FDA officials resigned" in 2005, after the "agency announced plans to indefinitely postpone any further review" of permitting OTC sales of Plan B. "Susan Wood, former director of the FDA's Office of Women's Health and one of the officials who resigned in 2005, thinks the changing political landscape could finally put an end to the decade-long controversy."

        Bloomberg News (4/6, Pearson, Armour) added that Korman "excoriated" the FDA for the delay in making Teva Pharmaceutical Industries' "Plan B, available over the counter. ... 'These emergency contraceptives would be among the safest drugs sold over the counter,' Korman wrote, and 'the number of 11-year-olds using these drugs is likely to be minuscule.'" FDA spokesperson Erica Jefferson "declined to comment on the ruling or the possibility of an appeal to the US Court of Appeals in New York."

        The Christian Science Monitor (4/6, Richey) said Korman, a "Reagan nominee, has presided over the Plan B litigation for years. In 2009, he ordered the Food and Drug Administration to expand availability of the drug without prescription to 17-year-olds."

        The Wall Street Journal (4/6, A3, Kendall, Anderson, Subscription Publication) reported that on Friday, Korman gave the FDA 30 days to lift the age restrictions from the Plan B emergency contraceptive and its generic equivalents. NBC News (4/6, Aleccia) in its "Vitals" blog added that Korman gave the FDA "the option of limiting the expanded access to the Plan B One-Step single-pill product if the agency 'actually believes there is any significant difference between the one- and two-pill products.'"

        The Philadelphia Inquirer (4/7, McCullough) noted that at present, the Plan B One-Step and Next Choice are "available without a prescription only to women 17 and older. The products are also kept behind the pharmacist's counter; purchasers must show a government-issued ID with proof of age."

        According to the Los Angeles Times (4/6, Morin) "Booster Shots" blog, the "ruling comes in response to a lawsuit filed by the Center for Reproductive Rights, which argued that restrictions placed on the drug imposed unreasonable delays for women of all ages" because the age prohibitions forced pharmacists to keep the products "behind counters so that they were not available outside regular business hours." US Department of Justice spokesperson Allison Price "said the government was 'reviewing the appellate options and expects to act promptly.'"

        Meanwhile, The Hill (4/5, Viebeck) "Healthwatch" blog noted that the Korman's decision "won praise from the medical community and supporters of abortion rights, who have litigated cases involving emergency contraception since 2001. 'Today science has finally prevailed over politics,' said" Center for Reproductive Rights CEO Nancy Northup.

        Similarly, CQ (4/6, Norman, Subscription Publication) said supporters "characterized the ruling as a major victory that will open the door to wider use of a safe and effective drug." Conversely, that puts "Obama and Sebelius on the side of some of the same groups that they are fighting in court over a separate requirement that all FDA-approved contraceptives - including the morning-after pill - be covered in workers' health insurance plans as preventive services under the health care law," CQ noted.

        In contrast, the Boston Globe (4/6, Kotz) reported that critics said the ruling means "young teens might indiscriminately incorrectly use the morning after pill as a method of birth control and that it might encourage sexual promiscuity. 'The decision will give young girls a serious drug,' said Anne Fox, president of the Massachusetts Citizens for Life, an antiabortion group. 'I think it's very irresponsible,'" Fox added. In the meantime, the Federal government is "expected to release its final rules for coverage of birth control methods such as oral contraception and intrauterine devices within the next few weeks."

        The ruling was also covered by the Atlantic (4/6, Hamblin), the New York Daily News (4/6, Marzulli, McShane), the New York Post (4/6, Maddux), Politico (4/6, Smith), the CNN (4/5, Landau) website, MSNBC (4/6, Cowley) on its website, the Time (4/6, Sifferlin) "Healthland" blog, the Dayton (OH) Daily News (4/6, McCarty), the Daily Caller (4/6, May), the NPR (4/6, Rovner) "Shots" blog, Reuters (4/6, Dye), BBC News (4/6), MedPage Today (4/6, Neale) and HealthDay (4/6, Reinberg).

        NYTimes: Ruling Admonishes Administration's Politically Motivated Decision. The editorial board of the New York Times (4/6, A16, Subscription Publication) opined that Korman's decision to overturn the Obama Administration's "ban preventing girls younger than 17 from purchasing emergency contraceptive" products OTC, was a "well-deserved rebuke to a politically motivated decision that overrode sound science and the health needs of young girls in order to placate political opponents of emergency contraception."

        NYSun: "Plan C" Should Deal With Parental Authority. The New York Sun (4/8) editorializes that Korman's ruling "has ignited quite an uproar" among parents on both "the right and left, including, it turns out, the President." Korman did not make it "his job to rule on the moral issues" or on "what one might call the good parenting issues," both of which are "better dealt with in the Congress or what we are sometimes prone to call 'Plan C.'" The Sun concludes that at this point, the "right move for Congress would be to reinforce the authority of the parents, who, after all, would be paying for any pills any 11 year old purchases."

        Bloomberg News: Sebelius Should Let Ruling Stand. Bloomberg News (4/5) editorialized that many physicians have "explained," that they oppose age restrictions because the morning-after products are "most effective if taken within 24 hours of unprotected sex" and quite often, there "isn't time for users to see a doctor before going to the pharmacy." In fact, Bloomberg News pointed out, "last November, the American Academy of Pediatrics recommended that its members work around the age restriction by prescribing the drug to teens in advance." The editorial also noted that several other physician groups, including the AMA, have voiced support for lifting the access restrictions on emergency contraceptives. Now, with the "presidential election that loomed" over Secretary Sebelius' "2011 action well past, she should let the judge's order stand," Bloomberg News concluded.

DIA Daily. This daily enewsletter features summaries of breaking news and information about the pharmaceutical, biotechnology, and medical device fields from thousands of global news sources. This easy-to-read enewsletter is delivered to your inbox every business morning.

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Obama Administration Finalizes Medicaid Expansion Regulations.

The Hill (3/29, Goad) "Regwatch" blog reported HHS finalized new regulations Friday that said "the federal government will reimburse states for 100 percent of the costs for some newly eligible Medicaid patients" for three years, and "after that, the federal contribution would be gradually phased down to 90 percent in 2020, and would remain there permanently." The rule was released after HHS Secretary Sebelius said this week that the new law "could cause healthcare costs to increase for some Americans. It was the first time a top administration official publicly made such a statement."

        The Washington Times (3/29, Howell) "Inside Politics" blog reported, "The Department of Health and Human Services announced it has proposed a final rule that describes a 'simple and accurate method' for states to claim the matching rate for enrollees deemed 'newly eligible' under the Affordable Care Act, which expands the program in 2014 to those making up to 133 percent of the federal poverty level."

        Modern Healthcare (3/30, Block, Subscription Publication) added that "although HHS on Friday released a final rule regarding the expanded 100% federal funding of the cost of new Medicaid beneficiaries, the department is still accepting comments on the methodology states can use to determine whether a new beneficiary qualifies for the enhanced funding."

        HHS To Allow Private Medicaid Expansion Option With Waiver. The Gannett News Service (3/29, Barton) reported that the Obama Administration "said Friday it would allow states to experiment with alternative approaches to the Medicaid expansion called for by the 2010 healthcare reform law." CMS provided "guidelines under which alternative or 'demonstration programs' could be established as a way of 'providing flexibility in pursuit of our shared goals,'" CMS Deputy Administrator Cindy Mann said. Several states are looking for something "other than a expansion of traditional Medicaid, something seen as politically tricky for those in conservative states."

        The Hill (3/29, Baker) "Healthwatch" blog reported that HHS said Friday that "states that want to privatize the healthcare law's Medicaid expansion will need a waiver from the federal government." HHS also "released a questions-and-answers document Friday explaining more about its approach to private expansions." The Hill points out that the privatization option "has gained traction since Arkansas Gov. Mike Beebe (D) first proposed it last month."

        The Washington Post (3/29, Kliff) "Wonkblog" reported that states that wanted "the so-called Arkansas option" to buy private insurance with Medicaid expansion money "have a few more answers." CMS "on Friday issued a Q&A to address some of the questions posed by states. It's not comprehensive - it includes three questions that span two pages - but it has a few new details that might help states make up their minds." Among the answers are that "a partial expansion isn't on the table," while "a waiver might be in order, though." Moreover, CMS said "benefits need to be comparable."

        Bloomberg News (3/29, Wayne) reported that CMS made "a departure" from the ACA and said Friday that "an unspecified number of states" will be able to use Medicaid money to allow low-income residents "to buy health insurance from private plans such as UnitedHealth Group Inc. or Humana Inc." CMS said it would allow the practice "as long as it doesn't cost the government more than the traditional Medicaid program." Arkansas and Ohio both have asked for permission to try private plans.

        Modern Healthcare (4/1, Blesch, Subscription Publication) notes that HHS will only grant a "limited number" of waivers.

        The National Journal (3/29, Sanger-Katz, Subscription Publication) reported that the Obama Administration on Friday "dampened...enthusiasm" in states that want to use private health plans to cover the poor, "laying out strict rules for the program that will interest only a few states." While "the details will reassure many Medicaid advocates," the "rules also could discourage some on-the-fence states from pursuing a Medicaid expansion at all, leaving more Americans without health insurance after the health law's biggest provisions kick in next year." The National Journal said Friday's announcement of rules "sets a high bar for the states to clear."

DIA Daily. This daily enewsletter features summaries of breaking news and information about the pharmaceutical, biotechnology, and medical device fields from thousands of global news sources. This easy-to-read enewsletter is delivered to your inbox every business morning.

Subscribe to the DIA Daily.
View archives.
iPhone and iPad Apps available! Download "BulletinHC."DIA Daily is a digest of the most important news selected from thousands of sources by the editors of BulletinHealthcare. The presence of content or advertising does not endorse, nor imply endorsement of, any products or services by the Drug Information Association. Neither BulletinHealthcare nor the Drug Information Association is liable for the use of or reliance on any information contained in this briefing.

If you would like more information about, or have a question pertaining to, DIA Membership and its benefits, please email membership@diahome.org.Click here to check your membership status.

Drug Information Association | 800 Enterprise Road, Suite 200 | Horsham, PA 19044
Copyright © 2012 by BulletinHealthcare| 11190 Sunrise Valley Drive, Suite 130 | Reston, VA 20191

Department of Health and Human Services - FDA - Medical Devices; Custom Devices; Request for Comments

[Federal Register Volume 77, Number 223 (Monday, November 19, 2012)]
[Notices]
[Page 69488]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28042]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1045]


Medical Devices; Custom Devices; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration Safety and Innovation Act 
(FDASIA), which was signed into law on July 9, 2012, amended the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act). The Food and Drug 
Administration (FDA) is in the process of developing an implementation 
strategy and policy for the custom device exemption criteria in the 
FD&C Act amended by FDASIA. FDA is seeking information on appropriate 
uses of the custom device exemption.

DATES: Submit either electronic or written comments by January 18, 
2013.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville MD 20852.

FOR FURTHER INFORMATION CONTACT: Bryan Benesch, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 3424, Silver Spring, MD 20993-0002, 301-796-5506.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 520(b) of the FD&C Act (21 U.S.C. 360j(b), as amended by 
section 617 of FDASIA (Pub. L. 112-144), sets forth the requirements 
that must be met in order for a device to qualify for a custom device 
exemption (Ref. 1). Section 520(b) of the FD&C Act exempts ``custom 
devices'' from performance standard or premarket approval requirements 
under sections 514 and 515 of the FD&C Act (21 U.S.C. 360d and 360e), 
if these devices meet the enumerated statutory requirements, including, 
among others, the following for each device: (1) Is ``created or 
modified in order to comply with the order of an individual physician 
or dentist (or any other specially qualified person designated under 
regulations promulgated by the Secretary after an opportunity for an 
oral hearing)''; (2) must not be ``generally available in the United 
States in finished form through labeling or advertising by the 
manufacturer, importer, or distributor for commercial distribution''; 
(3) must be for the purpose of treating a ``unique pathology or 
physiological condition that no other device is domestically available 
to treat''; and (4) must be manufactured for the ``special needs of 
such physician or dentist (or other specially qualified person so 
designated) in the course of the professional practice of the physician 
or dentist (or other specially qualified person so designated)'' or by 
an individual patient named in such order.
    In addition to these new requirements for establishing a custom 
device, manufacturers will have limitations for use of a custom device 
only for the purpose of treating a ``sufficiently rare condition, such 
that conducting clinical investigations on such device would be 
impracticable'' and production of the device must be limited to no more 
than five units per year of a particular device type. Lastly, 
manufacturers will be required to submit an annual report explaining 
their use of the custom device exemption under section 617 of FDASIA.
    FDA is seeking information on and examples of appropriate uses of 
the custom device exemption identified in section 520(b) of the FD&C 
Act. FDA encourages all stakeholders, including patients, physicians, 
dentists, and manufacturers, to submit comments on the appropriate use 
of this statutory provision.
    FDA is particularly interested in receiving information relating 
to:
    1. Input from patients, manufacturers, dentists, or physicians on 
where use of the custom device exemption is appropriate.
    2. Specific instances where manufacturers, dentists, or physicians 
have used, would have liked to use, or plan to use the custom device 
exemption for treatment of a sufficiently rare condition.
    3. Product areas other than orthopedic and dental devices where the 
custom device exemption may be useful.
    4. The type of information manufacturers intend to require a 
physician, dentist, or other qualified person to submit to them when 
ordering a custom device.
    5. How often a custom device is ordered due to unusual anatomical 
features of the individual physician/dentist, or due to a unique need 
in the physician's/dentist's practice not shared by health 
professionals of the same specialty (i.e., a special need of a 
physician or dentist).
    This notice provides the first opportunity for the public to 
comment on these issues. The public will have a second opportunity to 
provide input when the Agency announces the availability of a draft 
guidance document and a draft regulation for implementing section 
520(b) of the FD&C Act.

II. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES) and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday, and are 
available electronically at http://www.regulations.gov.
    1. The Food and Drug Administration Safety and Innovation Act, 
available at http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm20027187.htm.

    Dated: November 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28042 Filed 11-16-12; 8:45 am]
BILLING CODE 4160-01-P

What HHS Might Look Like Under President Romney - The Health Care Blog

By Dan Diamond

The world may not be ready for a Romney presidency.
Or more specifically: world leaders may not have done enough homework.

An interesting Washington Post story this week suggested that because the foreign polls have been so bullish on President Obama — 82% of Germans in one survey expected Obama to be re-elected — lawmakers around the world may be scrambling to adjust to a new team of U.S. diplomats and set of policies.

Is the health sector better prepared?

Given the close race — as of press time on Wednesday, most polls had the presidential race neck and neck — there’s been growing scrutiny of Republican health proposals. For example, the Kaiser Family Foundation and the Urban Institute on Tuesday released another report on the GOP House Budget Committee’s Medicaid plan.

But there’s been much less examination of the people who would steer Romney’s Department of Health and Human Services and the policies they’d carry out.

for more: What HHS Might Look Like Under President Romney

HHS Announces the First 26 Health Care Innovation Awards

The Department of Health and Human Services has announced the first round of organizations to receive funding through the Health Care Innovation Awards.

Authorized by the Affordable Care Act, the Health Care Innovation Awards will fund up to $1 billion in grants for projects that aim to improve care and lower costs for people enrolled in Medicare, Medicaid and Children's Health Insurance Program, as well as enhance the health care workforce. This first round of awards will support 26 innovative projects nationwide, which received a total of $122.6 million, and are projected to reduce health spending by $254 million over the next three years.

Several projects that received funding are focused on implementing strategies to improve care transitions to reduce hospital readmissions. These strategies include training and making use of care transition specialists and care management teams, implementing evidence based care transition programs for high-risk patients, and utilizing telehealth and other technology to coordinate care.
Please find attached a detailed summary of the first round of projects funded by the Health Care Innovation Awards.

For more information on the Health Care Innovation Awards, please click here.

Interactive database of profiles, http://www.innovations.cms.gov/initiatives/Innovation-Awards/Project-Profiles.html

taken from http://www.ntocc.org/News/tabid/59/post/hhs-announces-the-first-26-health-care-innovation-awards/Default.aspx

HHS innovator: Grants, challenges are growing healthcare entrepreneurs - from MedCityNews

When you hear “government” and “healthcare,” you probably think Medicare, Medicaid and other government programs directed at the general public.

Wil Yu

Wil Yu, director of innovations at the Department of Health and Human Services in the Office of the National Coordinator for Health IT, by contrast, wants to build an entrepreneurial ecosystem in the private sector to solve big healthcare problems.

His tools? Data liberacion and app challenges that are designed to help entrepreneurs think up and build the next innovative solution for problems facing the industry.

In his government job, the former investment banker and equity analyst:

• Leads several innovation grant programs and created “Investing in Innovations;“
• directs the Strategic Health IT Advanced Research Projects program;
• serves as a senior adviser at the CMS Innovation Center and on the HHS Innovation Council;
• manages the DC-to-VC program;
• and co-founded the Federal mHealth Collaborative.

He also has helped with many challenges that range from heart health to hospital-to-home transitions.
Yu talked with MedCity News about gaming and health, access to data, and the DC-to-VC program.

MedCity: Many people are skeptical about government’s role in innovation. How can you convince people that government is on their side?

for the full interview:
http://medcitynews.com/2012/05/hhs-innovator-government-is-supporting-innovative-ecosystem-in-healthcare/?utm_source=rss&utm_medium=rss&utm_campaign=hhs-innovator-government-is-supporting-innovative-ecosystem-in-healthcare

Donna Shalala, former HHS secretary, joins Brookings

By Allen McDuffee

The Brookings Institution has announced that Donna Shalala, former secretary of health and human services (HHS), will become a distinguished fellow at the think tank.

Donna Shalala (Associated Press) She will remain in her post at the University of Miami, where she has been president since 2001, and will serve at Brookings concurrently.
Shalala will draw on her role as secretary of HHS where she oversaw Social Security, Medicare and Medicaid in the work of the Economic Studies program at Brookings and its Engelberg Center for Health Care Reform.
“We are honored that Dr. Shalala will lend her expertise, experience, and boundless energy to Brookings’s efforts to improve public policy,” said Brookings President Strobe Talbott in a released statement.
“I am certain that her many years of outstanding public service will be invaluable as we address America’s critical economic and health policy challenges,” said Karen Dynan, vice president and co-director of Economic Studies at Brookings.

Please see link for full article:

By Allen McDuffee | 11:32 AM ET, 04/02/2012