34108
`
`Federal Register / Vol. 78, No. 109 / Thursday, June 6, 2013 / Notices
`
`DEPARTMENT OF HEALTH AND
`HUMAN SERVICES
`
`Food and Drug Administration
`
`[Docket No. FDA–2012–P–1034]
`
`Determination That SUBOXONE
`(Buprenorphine Hydrochloride and
`Naloxone Hydrochloride) Sublingual
`Tablets, 2 Milligrams/0.5 Milligrams
`and 8 Milligrams/2 Milligrams, Were
`Not Withdrawn From Sale for Reasons
`of Safety or Effectiveness
`
`AGENCY: Food and Drug Administration,
`HHS.
`ACTION: Notice.
`
`SUMMARY: The Food and Drug
`Administration (FDA) has determined
`that SUBOXONE (buprenorphine
`hydrochloride (HCl) and naloxone HCl)
`sublingual tablets, 2 milligrams (mg)/0.5
`mg and 8 mg/2 mg, were not withdrawn
`from sale for reasons of safety or
`effectiveness. This determination will
`allow FDA to approve abbreviated new
`drug applications (ANDAs) for
`buprenorphine HCl and naloxone HCl
`sublingual tablets, 2 mg/0.5 mg and 8
`mg/2 mg, if all other legal and
`regulatory requirements are met.
`FOR FURTHER INFORMATION CONTACT:
`David E. Markert, Center for Drug
`Evaluation and Research, Food and
`Drug Administration, 10903 New
`Hampshire Ave., Bldg. 51, Rm. 6248,
`Silver Spring, MD 20993–0002, 301–
`796–3602.
`SUPPLEMENTARY INFORMATION:
`
`I. Background
`In 1984, Congress enacted the Drug
`Price Competition and Patent Term
`Restoration Act of 1984 (Pub. L. 98–417)
`(the 1984 amendments), which
`authorized the approval of duplicate
`versions of drug products under an
`ANDA procedure. ANDA applicants
`must, with certain exceptions, show that
`the drug for which they are seeking
`approval contains the same active
`ingredient in the same strength and
`dosage form as the ‘‘listed drug,’’ which
`is a version of the drug that was
`previously approved. ANDA applicants
`do not have to repeat the extensive
`clinical testing otherwise necessary to
`gain approval of a new drug application
`(NDA).
`The 1984 amendments include what
`is now section 505(j)(7) of the Federal
`Food, Drug, and Cosmetic Act (21 U.S.C.
`355(j)(7)), which requires FDA to
`publish a list of all approved drugs.
`FDA publishes this list as part of the
`‘‘Approved Drug Products With
`Therapeutic Equivalence Evaluations,’’
`which is known generally as the
`
`‘‘Orange Book.’’ Under FDA regulations,
`drugs are removed from the list if the
`Agency withdraws or suspends
`approval of the drug’s NDA or ANDA
`for reasons of safety or effectiveness or
`if FDA determines that the listed drug
`was withdrawn from sale for reasons of
`safety or effectiveness (21 CFR 314.162).
`A person may petition the Agency to
`determine, or the Agency may
`determine on its own initiative, whether
`a listed drug was withdrawn from sale
`for reasons of safety or effectiveness.
`This determination may be made at any
`time after the drug has been withdrawn
`from sale, but must be made prior to
`approving an ANDA that refers to the
`listed drug (§ 314.161 (21 CFR 314.161)).
`FDA may not approve an ANDA that
`does not refer to a listed drug.
`SUBOXONE (buprenorphine HCl and
`naloxone HCl) sublingual tablets, 2 mg/
`0.5 mg and 8 mg/2 mg, are the subject
`of NDA 20–733, held by Reckitt
`Benckiser Pharmaceuticals, Inc.
`(Reckitt), and initially approved on
`October 8, 2002. SUBOXONE is
`indicated for maintenance treatment of
`opioid dependence.
`In a letter dated September 18, 2012,
`Reckitt notified FDA that SUBOXONE
`(buprenorphine HCl and naloxone HCl)
`sublingual tablets, 2 mg/0.5 mg and 8
`mg/2 mg, were being discontinued.
`Shortly thereafter, Reckitt publicly
`announced that it was discontinuing
`this product for safety reasons and that
`it had submitted a citizen petition
`requesting that FDA require all
`manufacturers of buprenorphine-
`containing products for the treatment of
`opioid dependence to implement
`certain public health safeguards (Ref.
`1).1 Reckitt later informed the Agency
`that it ceased distributing SUBOXONE
`sublingual tablets in March 2013, at
`which time FDA moved the product to
`the ‘‘Discontinued Drug Product List’’
`section of the Orange Book.
`Lachman Consultant Services, Inc.
`(Lachman), submitted a citizen petition
`dated September 27, 2012 (Docket No.
`FDA–2012–P–1034), under 21 CFR
`10.30, requesting that the Agency
`
`1 The citizen petition (Docket No. FDA–2012–P–
`1028), which was submitted on September 25, 2012,
`also requested that FDA refuse to approve any
`ANDAs for buprenorphine HCl and naloxone HCl
`products for opioid dependence until the Agency
`determined whether SUBOXONE sublingual tablets
`were discontinued for safety reasons. In its
`February 22, 2013, response to the citizen petition,
`FDA concluded that this request was premature
`because Reckitt had not yet withdrawn SUBOXONE
`sublingual tablets from sale. Nonetheless, the
`Agency conducted a full review and analysis of the
`safety issues raised in Reckitt’s citizen petition and
`determined, on the basis of the data available at that
`time, that withdrawal of SUBOXONE sublingual
`tablets from sale was not necessary for reasons of
`safety.
`
`determine whether SUBOXONE
`(buprenorphine HCl and naloxone HCl)
`sublingual tablets, 2 mg/0.5 mg and 8
`mg/2 mg, were withdrawn from sale for
`reasons of safety or effectiveness. The
`petitioner noted that Reckitt had
`publicly announced that it was
`discontinuing this product.
`After considering Lachman’s citizen
`petition and reviewing our records,
`including the safety analysis that the
`Agency prepared in connection with
`Reckitt’s citizen petition, FDA has
`determined under § 314.161 that
`SUBOXONE (buprenorphine HCl and
`naloxone HCl) sublingual tablets, 2 mg/
`0.5 mg and 8 mg/2 mg, were not
`withdrawn for reasons of safety. We
`described the basis for this
`determination in our letter response to
`Reckitt’s citizen petition (available at
`http://www.regulations.gov under
`Docket No. FDA–2012–P–1028). Since
`the issuance of that response, we have
`updated our reviews of relevant
`literature and data on this product. We
`found no additional information during
`this process that would indicate that
`SUBOXONE (buprenorphine HCl and
`naloxone HCl) sublingual tablets, 2 mg/
`0.5 mg and 8 mg/2 mg, were, or should
`have been, withdrawn from sale for
`reasons of safety.
`FDA has also determined under
`§ 314.161 that SUBOXONE
`(buprenorphine HCl and naloxone HCl)
`sublingual tablets, 2 mg/0.5 mg and 8
`mg/2 mg, were not withdrawn for
`reasons of effectiveness. We have
`reviewed our records and other relevant
`data sources, and have found no
`information that would indicate that
`this product was ineffective as a
`maintenance treatment of opioid
`dependence.
`Accordingly, the Agency will
`continue to list SUBOXONE
`(buprenorphine HCl and naloxone HCl)
`sublingual tablets, 2 mg/0.5 mg and 8
`mg/2 mg, in the ‘‘Discontinued Drug
`Product List’’ section of the Orange
`Book. The ‘‘Discontinued Drug Product
`List’’ delineates, among other items,
`drug products that have been
`discontinued from marketing for reasons
`other than safety or effectiveness.
`ANDAs that refer to SUBOXONE
`(buprenorphine HCl and naloxone HCl)
`sublingual tablets, 2 mg/0.5 mg and 8
`mg/2 mg, may be approved by the
`Agency as long as they meet all other
`legal and regulatory requirements for
`the approval of ANDAs. If FDA
`determines that labeling for this drug
`product should be revised to meet
`current standards, the Agency will
`advise ANDA applicants to submit such
`labeling.
`
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`Federal Register / Vol. 78, No. 109 / Thursday, June 6, 2013 / Notices
`
`34109
`
`II. References
`
`The following reference has been
`placed on display in the Division of
`Dockets Management (HFA–305), Food
`and Drug Administration, 5630 Fishers
`Lane, Rm. 1061, Rockville, MD 20852,
`and may be seen by interested persons
`between 9 a.m. and 4 p.m., Monday
`through Friday, and is available
`electronically at http://
`www.regulations.gov. (FDA has verified
`the Web site address in this reference
`section, but FDA is not responsible for
`any subsequent changes to the Web site
`after this document publishes in the
`Federal Register.)
`
`1. ‘‘Further US RB Pharmaceuticals
`Announcement,’’ http://www.rb.com/site/
`rkbr/templates/mediainvestors
`general2.aspx?pageid=1332&cc=GB,
`Reckitt Benckiser Group plc, September 25,
`2012. Web. May 17, 2013.
`
`Dated: May 31, 2013.
`Janet Woodcock,
`Director, Center for Drug Evaluation and
`Research.
`[FR Doc. 2013–13446 Filed 6–5–13; 8:45 am]
`
`BILLING CODE 4160–01–P
`
`DEPARTMENT OF HEALTH AND
`HUMAN SERVICES
`
`Food and Drug Administration
`
`[Docket No. FDA–2013–N–0012]
`
`‘‘Script Your Future’’ Medication
`Adherence Campaign
`
`AGENCY: Food and Drug Administration,
`HHS.
`ACTION: Notice.
`
`SUMMARY: The Food and Drug
`Administration (FDA) is announcing the
`availability of grant funds for the
`continuing support of a national effort
`to promote the importance of
`medication adherence to enhance the
`health of Americans. Medication
`adherence is taking medicine as
`directed to treat an illness or disease in
`order to get the best health outcome
`possible for each patient. Nearly three
`out of four Americans report that they
`do not take their medication as directed.
`One in three people never fill their
`prescriptions. The annual price tag for
`medication adherence failure is
`estimated to be $290 billion, and the
`impact on the medical system and
`patients from this lack of adherence may
`result in relapses or recurrences of
`medical symptoms, increases in hospital
`visits, or even death. FDA is committed
`to addressing this issue, which has
`enormous implications for public health
`and the U.S. economy, by, in part,
`
`continuing its financial and other
`contributions to a carefully planned,
`well-executed effective national
`campaign begun in 2010 by the National
`Consumers League (NCL) called ‘‘Script
`Your Future’’.
`To continue and enhance this
`important public health initiative, the
`Division of Health Communications
`(DHC)/Office of Communications
`(OCOMM)/Center for Drug Evaluation
`and Research (CDER) in FDA seeks to
`assist the National Consumers League in
`the development of new online
`resources and tools for patients,
`engagement of public and private
`partners to build on and complement
`existing medication adherence
`programs, education of health care
`professionals with strategies to share
`with patients, continuous evaluation of
`the campaign to enhance and improve
`it, expansion of public-private
`partnerships, strengthening of this
`national forum focused on informing
`consumers about medication adherence,
`and tailoring messaging to
`subpopulations of consumers who may
`need adaptations or special efforts to
`inform and educate them.
`DATES: Important dates are as follows:
`1. The application due date is July 1,
`2013.
`2. The anticipated start date is August
`2013.
`3. The opening date is the date this
`announcement is published in the
`Federal Register.
`4. The expiration date is July 2, 2013.
`ADDRESSES: Submit the paper
`application to: Gladys Melendez, Grants
`Management (HFA–500), Food and Drug
`Administration, 5630 Fishers Lane, Rm.
`2032, Rockville, MD 20857; and a copy
`to Elaine Frost, Center for Drug
`Evaluation and Research, Food and
`Drug Administration, 10001 New
`Hampshire Ave., Rm. 1140, Silver
`Spring, MD 20903. For more
`information, see section III of the
`SUPPLEMENTARY INFORMATION section.
`FOR FURTHER INFORMATION CONTACT:
`Paula Rausch, Center for Drug
`Evaluation and Research, Food and
`Drug Administration, 10001 New
`Hampshire Ave., Rm. 4110, Silver
`Spring, MD 20903, 301–796–3121; or
`Gladys Melendez, Grants Management
`Branch (HFA–500), Food and Drug
`Administration, 5630 Fishers Lane, Rm.
`2032, Rockville, MD 20857, 301–827–
`7175.
`For more information on this funding
`opportunity announcement (FOA) and
`to obtain detailed requirements, please
`obtain the full FOA from
`gladys.bohler@fda.hhs.gov.
`SUPPLEMENTARY INFORMATION:
`
`I. Funding Opportunity Description
`Request for Application: FDA–RFA–
`13–027.
`
`Catalog of Federal Domestic Assistance:
`93.103
`
`A. Background
`In order to fulfill FDA’s mission to
`protect public health by assuring the
`safety, efficacy, and security of human
`drugs; and helping the public to obtain
`the accurate, science-based information
`they need to use medications in ways
`that maintain and improve their health,
`FDA seeks to continue its participation
`in a national campaign aimed at
`promoting the importance of medication
`adherence to enhance the health of
`Americans.
`FDA recognizes medication adherence
`as a formidable health problem that
`results in health system and human
`costs that adversely impact our nation.
`FDA has a responsibility as a public
`health agency to educate and inform the
`public and health professionals about
`the importance of medication
`adherence. Since 2010, FDA has been a
`key government stakeholder in the
`NCL’s initiative, along with other major
`government agencies and private and
`nonprofit organizations, to address the
`issue of poor medication adherence.
`FDA is committed to educating and
`informing the public about this issue,
`including key subpopulations such as
`those with low literacy and health
`literacy, or that faces health disparities
`or is economically disadvantaged.
`The NCL is the nation’s oldest
`consumer organization. With FDA and
`its other government partners, NCL
`launched its nationwide ‘‘Script Your
`Future’’ campaign in 2010 to address
`the issue of poor medication adherence.
`NCL possesses an extensive research
`and evaluation framework from past
`medication outreach efforts that helped
`ensure the campaign’s medication
`adherence messages and materials are
`based on sound communication science.
`In addition, NCL assembled a coalition
`of more than 130 public-private partners
`to mobilize resources that can increase
`awareness and outreach to the public far
`beyond what FDA would be able to do
`alone to promote increased
`understanding and positive actions
`among the general public and health
`professionals related to this critical
`issue. Future NCL plans are in sync
`with FDA goals for a national
`medication adherence campaign and
`FDA seeks to enhance this carefully
`designed communications intervention.
`FDA has been and remains a key partner
`with NCL on issues pertaining to the
`safe use of medicines.
`
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