[Sign Up Now] to Receive Our FREE Daily SCVTV-SCVNews Digest by E-Mail

Inside
Weather
Santa Clarita CA
Intermittent clouds
Intermittent clouds
70°F
 
Calendar
Today in
S.C.V. History
May 24
1860 - Colonel Thomas F. Mitchell arrives in Soledad Canyon [story]


[Health and Human Services Secretary Kathleen Sebelius] – Plan B One-Step is an emergency contraceptive, sometimes referred to as the “morning after pill.” Plan B One-Step is currently labeled over the counter to women ages 17 years and older, but is sold behind the pharmacy counter. It is available by prescription only to women 16 years and younger. My decision does not change any current availability of the drug for all women.

In February 2011, Teva Women’s Health Inc. submitted to the FDA a supplemental new drug application for Plan B One-Step. This application sought to make Plan B One-Step available over the counter for all girls of reproductive age. The science has confirmed the drug to be safe and effective with appropriate use. However, the switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately. I do not believe that Teva’s application met that standard. The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use.

FDA has recommended approval of this application in its Summary Review for Regulatory Action on Plan B One-Step. After careful consideration of the FDA Summary Review, I have concluded that the data, submitted by Teva, do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age.

The average age of the onset of menstruation for girls in the United States is 12.4 years. However, about ten percent of girls are physically capable of bearing children by 11.1 years of age. It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age. If the application were approved, the product would be available, without prescription, for all girls of reproductive age.

The Secretary of the Department of Health and Human Services is responsible, acting through the FDA Commissioner, for executing the Federal Food, Drug, and Cosmetic Act. Today’s action reflects my conclusion that the data provided as part of the actual use study and the label comprehension study are not sufficient to support making Plan B One-Step available to all girls 16 and younger, without talking to a health care professional. Plan B One-Step will still be available over the counter to women ages 17 and older.

Because I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age, I have directed FDA to issue a complete response letter denying the supplemental new drug application (SNDA) by Teva Women’s Health, Inc.

=====

Statement from FDA Commissioner Margaret Hamburg, M.D. on Plan B One-Step

The U.S. Food and Drug Administration (FDA) has been carefully evaluating for over a decade whether emergency contraceptives containing levonorgestrel, such as Plan B One-Step, are safe and effective for nonprescription use to reduce the chance of pregnancy after unprotected sexual intercourse.

Plan B One-Step is a single-dose pill (1.5 mg levonorgestrel tablet) which is effective in decreasing the chance of pregnancy if taken within 3 days after unprotected sexual intercourse.  The product contains higher levels of a hormone found in some types of daily use oral hormonal contraceptive pills and works in a similar way to birth control pills.

Plan B One-Step was originally approved in July 2009 for use without a prescription for females age 17 and older and as a prescription-only option for females younger than age 17.  In February 2011, Teva Women’s Health Inc. submitted a supplemental application seeking to remove the prescription-only status for females younger than age 17 and to make Plan B One-Step nonprescription for all females of child-bearing potential.

The Center for Drug Evaluation and Research (CDER) completed its review of the Plan B One-Step application and laid out its scientific determination. CDER carefully considered whether younger females were able to understand how to use Plan B One-Step.  Based on the information submitted to the agency, CDER determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.

It is our responsibility at FDA to approve drugs that are safe and effective for their intended use based on the scientific evidence.  The review process used by CDER to analyze the data applied a risk/benefit assessment consistent with its standard drug review process.  Our decision-making reflects a body of scientific findings, input from external scientific advisory committees, and data contained in the application that included studies designed specifically to address the regulatory standards for nonprescription drugs.  CDER experts, including obstetrician/gynecologists and pediatricians, reviewed the totality of the data and agreed that it met the regulatory standard for a nonprescription drug and that Plan B One-Step should be approved for all females of child-bearing potential.

I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER, and I agree with the Center that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.

However, this morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential.   Because of her disagreement with FDA’s determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved.  Following Secretary Sebelius’s direction, FDA sent the complete response letter to Teva today.  Plan B One-Step will remain on the market and will remain available for all ages, but a prescription will continue to be required for females under the age of 17.

Comment On This Story
COMMENT POLICY: We welcome comments from individuals and businesses. All comments are moderated. Comments are subject to rejection if they are vulgar, combative, or in poor taste.
REAL NAMES ONLY: All posters must use their real individual or business name. This applies equally to Twitter account holders who use a nickname.

0 Comments

You can be the first one to leave a comment.

Leave a Comment


SCV NewsBreak
LOCAL NEWS HEADLINES
Thursday, May 24, 2018
COC Student-Athlete, Route 91 Survivor Set to Graduate
With a minute left on the clock, College of the Canyons soccer team captain Hailey Phipps scored a goal from 16 yards outside the box, lifting the Cougars to a 1-0 win against Moorpark College.
Thursday, May 24, 2018
Firefighters Douse Trash Truck Fire in Canyon Country
Firefighters were dispatched Thursday afternoon to a trash truck fire in Canyon Country.
Thursday, May 24, 2018
Wallet Thefts While Shopping on the Rise
The Santa Clarita Valley Sheriff's Station has issued a warning regarding an increase in thefts of wallets stolen from women's purses as they are shopping. Here is the advisory from the station's Facebook page:
Keep Up With Our Facebook

Latest Additions to SCVNews.com
We must begin to start solving problems and building bridges for our veteran community. We must connect them with the services they need and have earned, and we must help them find mortgage-paying jobs that support them and their families now and into the future.
Honor Fallen Vets by Supporting Survivors | By Sen. Scott Wilk
College of the Canyons Small Business Development Center will host the following Business Events and Training Webinar:
COC Small Business Development Center to Host Business Events, Training Webinar
With a minute left on the clock, College of the Canyons soccer team captain Hailey Phipps scored a goal from 16 yards outside the box, lifting the Cougars to a 1-0 win against Moorpark College.
COC Student-Athlete, Route 91 Survivor Set to Graduate
During the month of May, volunteer drivers for the Santa Clarita Valley Senior Center’s “Meals on Wheels” program are receiving CPR training thanks to a partnership with Henry Mayo Newhall Hospital, LBW Insurance and Financial Services and Superior Life Support, Inc.
Meals on Wheels Drivers to Receive CPR Training
Firefighters were dispatched Thursday afternoon to a trash truck fire in Canyon Country.
Firefighters Douse Trash Truck Fire in Canyon Country
The College of the Canyons Athletics department recently hosted its annual Student-Athlete Academic Achievement Dinner, honoring more than 90 student-athletes who will be earning an associate degree this semester and/or transferring to a four-year school in the fall.
More than 90 COC Student-Athletes Advance Towards Graduation
Calling all Yogis or Yogis-in-Training.
June 1: Goat Yoga for a Cause
College of the Canyons is co-sponsoring a National Conference on Manufacturing here in Santa Clarita on June 4 and 5.
June 4,5: National Coalition of Advanced Technology Centers Summer Workshop
California State University, Northridge film professor Nate Thomas has earned a second regional Emmy Award nomination for a television public service announcement (PSA) campaign he directed and produced for the FBI on cybercrimes.
CSUN Film Professor Earns Another Emmy Nod for FBI PSA
The Los Angeles metropolitan area harbors the largest homeless population in the United States of America.
CSUN Prof’s Photo Exhibit, ‘One of Us,’ Documents Stories of LA’s Homeless
Get ready for the sounds of live Jazz and Blues bands to once again fill Town Center Drive in Valencia.
June 15: Opening Night Valencia Jazz, Blues Concert Series
NORTHRIDGE - CSUN Baseball (26-29) wraps up the 2018 season this weekend at USC. The Matadors and Trojans open up a three-game series Thursday at 6 p.m. while game two is set for Friday at 6 p.m. and the season finale is scheduled for Saturday at 2 p.m. All three games will be streamed live on Pac-12.com.
Matadors Wrap Up 2018 Season with Weekend Series Against Trojans
NORTHRIDGE, Calif.---CSUN Men's Basketball head coach Mark Gottfried finalized his coaching staff with the additions of former National Coach of the Year Jim Harrick, 30-year collegiate coach Jeff Dunlap and NBA champion Mo Williams. The trio will serve as assistant coaches for the 2018-19 season.
Jim Harrick, Mo Williams to Join CSUN Basketball Coaching Staff
LAKE ELSINORE – For the second-consecutive day the JetHawks were held to one run in a 4-1 loss to the Lake Elsinore Storm on Wednesday night at The Diamond.
JetHawks Held to 1 Run for Second-Consecutive Day
The Los Angeles County Department of Parks and Recreation kicks off its public summer swim season beginning Saturday, June 2, 2018, with the opening of six swimming pools for free recreational swimming.
County Announces 2018 Summer Pool Openings
The Valley Industry Association is pleased to host Jonathan Miller, Vice President of Clinical Support and Facility Planning, and Fellow of the American College of Healthcare Executives and Sevan Stepanian, MD, Urology, fellowship-trained in minimally invasive and robotic surgery, as keynote speakers for the June luncheon meeting.
June 19: Valley Industry Association Luncheon Meeting
The Santa Clarita Valley Sheriff's Station has issued a warning regarding an increase in thefts of wallets stolen from women's purses as they are shopping. Here is the advisory from the station's Facebook page:
Wallet Thefts While Shopping on the Rise
The Santa Clarita City Council Legislative Committee will hold a meeting Friday, May 25, at 11:00 a.m.
May 25: City Council Legislative Committee Meeting
1860 - Colonel Thomas F. Mitchell arrives in Soledad Canyon [story]
Santa Clarita ranks No. 182 -- dead last -- among the best cities in which to launch a post-college career, according to a new survey by WalletHub, and SCV Chamber Board Chairman Troy Hooper comments.
WalletHub Survey: Santa Clarita the Worst U.S. City to Launch a Career
In Wednesday's Peace Officers' Memorial Ceremony at the Eugene W. Biscailuz Regional Training Center in East Los Angeles, LASD Sheriff Jim McConnell honored five fallen heroes whose names were added to the Peace Officers’ Memorial Wall.
Sheriff McDonnell Holds Peace Officers’ Memorial Ceremony, Wall Dedication
The Santa Clarita Valley Chamber of Commerce is pleased to announce that the Secretary of the California Department of Veterans Affairs, Dr. Vito Imbasciani, will serve as Honorary Chair of the 8th Annual Patriots Luncheon, honoring local veterans on Thursday, July 12 at The Oaks Club in Valencia.
July 12: CalVet Secretary Set as Honorary Chair of Patriots Luncheon
Recent TMU graduate Samuel Eisenhuth finished school with a 4.0 GPA and a lasting impact on the golf program.
Eisenhuth Leads TMU Golf ‘with God in Mind’
The Los Angeles County Board of Supervisors voted unanimously Tuesday to develop guidelines to fast-track removal or reduction of cannabis-related convictions for county residents, many of whom face barriers to employment, housing and public benefits due to their records.
LA County Moves to Clear Pot-Related Convictions
Graphic Design faculty Michael Worthington devised a plan to consolidate CalArts' poster archive into a digital space so the works are available online to alumni and current students, as well as to CalArts and design communities at large.
Time Traveling Through the CalArts Poster Archive Online
The editors of College of the Canyons’ award-winning literary and arts magazine "cul-de-sac" invite the community to celebrate the publication's 11th annual volume with a night of poetry, prose, photography and art at COC’s Valencia campus on Friday, May 25, from 5 p.m. to 9 p.m.
May 25: Publication Party for COC’s ‘cul-de-sac’ Literary, Arts Magazine
The Los Angeles County Registrar-Recorder/County Clerk would like to partner with local community organizations to host and facilitate community meetings for the county's Vote Center Placement Project.
LA County Seeks Community Input on Vote Center Locations
Six Flags Hurricane Harbor in Valencia will open for its 24th season on Saturday, May 26 with more than 23 unique slides and attractions for the entire family.
May 26: Six Flags Hurricane Harbor to Open for Season
The Santa Clarita Valley Senior Center Silvertone Singers under the direction of John Swinford will sing a set of TV themes old and new at the Senior Center in Newhall on Thursday, May 24, from 2:45 p.m. to 4:30 p.m.
May 24: Silvertone Singers to Warble TV Themes at SCV Senior Center
Rico Garcia delivered another strong outing, but the JetHawks failed to provide him with run support in a series-opening 2-1 loss to the Lake Elsinore Storm on Tuesday night at The Diamond.
JetHawks Drop Storm Opener 2-1 Despite Garcia Gem
The Herb Alpert Foundation and California Institute of the Arts awarded the 24th Annual Herb Alpert Award in the Arts to five exceptional mid–career artists at a lunch hosted by the Herb Alpert Foundation in Santa Monica on May 18.
CalArts Names 5 Herb Alpert Award Recipients for 2018
Santa Clarita franchise partner Francis James has opened a new Expedia CruiseShipCenters location at 26512 Bouquet Canyon Road, in the Bouquet Center Shopping Center at the corner of Newhall Ranch Road in Saugus.
Expedia Cruise Ship Centers Drop Anchor in Santa Clarita
The County of Los Angeles Department of Animal Care and Control will partner with Animals for Armed Forces Foundation to provide free adoptions for veterans, reserve, active duty service members and immediate family members during Memorial Day weekend, May 25-27.
May 25-27: Pet Adoption Fees at County Shelters Waived for Veterans
The Los Angeles County Fire Department will conduct its annual live wildfire training exercises at Pitchess Detention Center, Wayside Honor Rancho in Castaic from June 4 through June 29.
June 4-29: Wildland Fire Training at Pitchess in Castaic
Santa Clarita Valley Sheriff's Station deputies arrested a young transient on drug charges in Stevenson Ranch Sunday afternoon, according to station officials.
Transient Arrested on Drug Charges in Stevenson Ranch
1941 - SCV's first real movie house, the American Theater, dedicated in Newhall [story]