Tag Archives: Access
THURSDAY May 2, 2013 — The Obama administration announced late Wednesday that it would appeal a federal judge’s order to eliminate any age restrictions on who can buy morning-after birth control pills without a prescription.
The move follows a Tuesday decision by the U.S. Food and Drug Administration to lower the age at which females can buy the Plan B One-Step morning-after pill — girls age 15 years of age and older will now have access, compared to the prior limit of 17.
With Wednesday’s appeal, the federal government has indicated that it only wants to ease access to emergency contraception by a certain degree, the Associated Press reported.
“Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States,” FDA Commissioner Dr. Margaret Hamburg said in an agency news release.
“The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly and that it does not prevent the transmission of a sexually transmitted disease,” she said.
The emergency contraceptive is made by Teva Women’s Health Inc.
To prevent girls under the age of 15 from buying Plan B, the FDA said the product would bear a label stating that proof of age be required, and a special product code would prompt such an inquiry from the cashier. “In addition, Teva has arranged to have a security tag placed on all product cartons to prevent theft,” the FDA noted.
On April 5, Judge Edward Korman, from the Eastern District of New York, gave the FDA 30 days to remove age restrictions on the sale of emergency contraception, such as Plan B One-Step. Until then, girls 16 and younger needed a doctor’s prescription to get the pill, which typically works if taken within 72 hours after intercourse.
Other brands of emergency contraception include Next Choice and Ella.
Wednesday’s appeal by the Justice Department is in keeping with an election-year decision by President Barack Obama’s administration to block the drug’s makers from selling it without a prescription or age restriction. And it reignites the hotly contested debate over emergency contraception, The New York Times reported.
The appeal meshes with the views of numerous conservative, anti-abortion groups that don’t want contraceptives available to young girls. But it clashes with advocates for women’s reproductive health and abortion rights who say years of scientific research found Plan B safe and effective for women of all ages, the Times said.
“Age barriers to emergency contraception are not supported by science, and they should be eliminated,” Cecile Richards, the president of Planned Parenthood Federation of America, said in a statement on Wednesday.
The appeal is the latest development in a 10-year, controversial debate about who should have access to the drug and why.
Plan B prevents implantation of a fertilized egg in a woman’s uterus through use of levonorgestrel, a synthetic form of the hormone progesterone used for decades in birth control pills. Plan B contains 1.5 milligrams of levonorgestrel, more than “the Pill” contains. It is considered a form of birth control, not abortion.
Women’s health advocates praised the FDA decision earlier this week.
“While there are still practical questions to resolve, this is an important step forward to expand access to emergency contraception and for preventing unintended pregnancy,” Planned Parenthood’s Richards said in a news release.
But not everyone was pleased with the push for wider access to Plan B.
Earlier this month, Janice Shaw Crouse — director and senior fellow at the Beverly LaHaye Institute, a think tank for the conservative women’s group Concerned Women for America — called Korman’s ruling “a political decision, made by those who stand to profit financially from an action that puts ideology ahead of the nation’s girls and young women.”
“It is irresponsible to advocate over-the-counter use of these high-potency drugs, which would make them available to anyone — including those predators who exploit young girls,” Shaw Crouse said.
In his ruling, Korman dismissed the federal government’s earlier arguments and, in particular, previous decisions by U.S. Health and Human Services Secretary Kathleen Sebelius that required girls under 17 to get a prescription for the emergency contraceptive. Korman wrote that Sebelius’ actions “with respect to Plan B One-Step … were arbitrary, capricious and unreasonable.”
In 2011, Sebelius overruled a recommendation by the FDA to make the drug available to all women without a prescription. The FDA said at the time that it had well-supported scientific evidence that Plan B One-Step was a safe and effective way to prevent unintended pregnancy.
Sebelius, however, said she was concerned that very young girls couldn’t properly understand how to use the drug without assistance from an adult.
She invoked her authority under the federal Food, Drug and Cosmetic Act and directed FDA Commissioner Hamburg to issue “a complete response letter.” As a result, “the supplement for nonprescription use in females under the age of 17 is not approved,” Hamburg wrote at the time.
The Mayo Clinic has more about emergency contraception.
Posted: May 2013
“They are no different than a guy selling dimebags in the back of a van in Pacific Beach.”
Those are the words that the top commander of the San Diego DEA Acting Special Agent in charge, William Sherman, chose to describe the large number medical marijuana delivery services in an interview with NBC San Diego7 on Tuesday.
Since September of 2011, over 230 storefront medical marijuana dispensaries have been shut down across San Diego by federal and local law enforcement agencies. During the costly raids, tens of millions of dollars in inventory and money were seized by businesses that thought they were operating legally under California’s Prop215 and SB420.
But the crackdown on that booming business of medical marijuana dispensaries has caused an explosion of delivery services across San Diego. And now they find themselves in the DEA’s crosshairs.
In the same interview, Sherman refers to medical marijuana delivery services as drug dealers and cites claims that delivery drivers travel with armed guards and bring added violence to neighborhoods. A simple Google search will turn up far more headlines about robberies and violence during the delivery of pizzas than those regarding the delivery of marijuana.
Sherman and his office have thrown down the gauntlet, announcing that his goal is to have the current crop of medical cannabis delivery services shut down by the summer. Medical marijuana advocates, meanwhile, say police are cutting off what’s left of safe access for patients who can’t or don’t grow their own now that storefronts aren’t around.
Among those leading the charge is Eugene Davidovich and the San Diego chapter of Americans for Safe Access (ASA). In a statement released on his Facebook page, dated February 27th, Davidovich addresses the DEA and U.S. Attorney Laura Duffy directly, saying:
“If you think the community will sit by quietly while you attempt to shutter the last traces of access to medical cannabis that exist in San Diego, then you have another thing coming. We will not rest until you are held accountable for this attack and your previous attacks on patients. It is time for you to end this interference in state law and vindictive eradication effort. San Diego elected officials and community members deserve to regulate a medicine that has been legal in the State for 16 years without this federal interference.”
Joining the growing resistance to this war on medical marijuana in San Diego (and lending the power of his pulpit to the debate) is newly-elected San Diego Mayor, Bob Filner.
Filner is an outspoken advocate of medical marijuana and its known benefits, and was swept into office last November on a wave of support from the cannabis community.
The edge Filner held in the late polls – and wound up winning by – was a near mirror image of the estimated number of marijuana users in San Diego. Hardly a coincidence and a fact that surely was not lost on Filner once he took office. Since a very public showdown with City Attorney Jan Goldsmith in January of this year, the Mayor’s office has been busily working with advocacy and patients’ rights groups to draft an ordinance that they feel will pass a razor thin 5-4 majority in the City Council.
That hearing was scheduled to take place on March 5th, but has already been postponed by at least a week or two, according to the Mayor’s office. In the meantime, statements like those being made in the media by the DEA, as well as city and state attorneys leave a lot of patients in limbo.
The pending ordinance hearing could either be a closing chapter in the story of the San Diego medical marijuana scene or – hopefully — a new beginning.
Beware the ides of March
Jack Daniel is a new freelance writer with Toke of the Town. He enjoys teaching the Macarena to zoo animals and loves long walks on the beach with a spliff in his hand. Look for more from Daniel in the coming weeks.
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US Consumer Product Safety Commission – Recent Recalls and Product Safety News
Citizens for Patient Rights announced on Friday that an initiative to allow and regulate medical marijuana dispensaries will appear on the November ballot in the City of Solana Beach, California. On Wednesday, July 25, the Solana Beach City Council voted unanimously to put the initiative proposal to a vote of the people.
“This is a great development for the patients and caregivers of Solana Beach, and for the over 1,800 Solana Beach residents who voiced their desire to have a vote for safe access on the November ballot by signing the initiative petition,” said James Schmachtenberger, of the Patient Care Association, which has supported the signature gathering effort.
“We applaud the Solana Beach City Council for listening to the voice of their constituents and allowing the democratic process to move forward,” said Cynara Velazquez, campaign consultant for Citizens for Patient Rights.
The initiative proposal would allow for not-for-profit medical marijuana dispensaries in the municipality of Solana Beach, providing they are in full compliance with the zoning, licensing and operating standards included in the initiative. Dispensaries would be limited to commercial and industrial zones, 600 feet away from schools or playgrounds, and 1,000 feet from any neighboring dispensary.
They would have to comply with safety measures such as lighting, alarm systems, cameras and security guards. Dispensaries would also have to adhere to strict operating standards, including local licensing, proof of full compliance with state law, not-for-profit status, patient verification requirements.
Citizens for Patient Rights is engaged in similar initiative efforts in supportive communities around San Diego County, California. An initiative for safe access has also qualified for the ballot in Del Mar, another is being considered by the City Council in Lemon Grove, and in Encinitas, the initiative petition has been submitted and is being qualified by the registrar of voters.
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Fifteen percent of registered voters in Imperial Beach, California have signed the initiative to overturn the city’s current ban on safe access to medical cannabis and replace it with reasonable regulations.
The Safe Access Ordinance of Imperial Beach, a collaborative effort between Canvass for a Cause, a San Diego based LGBT non-profit, San Diego Americans for Safe Access, and concerned citizens, launched the first ever initiative to regulate safe access to medical cannabis in Imperial Beach. If passed, the measure would repeal the city’s current ban and replace it with strict zoning regulations and operational requirements for medical cannabis dispensing collectives and cooperatives.
Friday at 11 a.m. representatives from the Safe Access IB campaign submitted more than 1500 valid signatures to the Imperial Beach City Clerk, enough to qualify the initiative for a special election.
“Our goal is to qualify enough signatures to put this ordinance on the November 2012 ballot,” said Rachel Scoma, attorney and treasurer for Safe Access of IB. “To ensure this happens, we are submitting enough signatures to qualify for a Special Election — this means, if officials from Imperial Beach drag their feet qualifying the initiative, they will have to spend thousands of dollars for a Special Election sometime next year.
“Through our own internal verification process we know these are all registered, Imperial Beach residents,” Scoma said. “We don’t want to, but we are ready to take legal action in defending the signatures.”
Since the start of the campaign, activists have gathered more than 2,600 signatures from individuals living in Imperial Beach, 600 more than originally planned and have spent less then $ 5,000 on the signature gathering effort.
“The support in Imperial Beach was overwhelming. Residents from both sides of the aisle are concerned about patients having safe access to their medication. This initiative will give an opportunity for voters in Imperial Beach to decide whether they want regulations that bring safe access for patients as well as create a safe community or allow city council to continue to criminalize the most vulnerable members of our community through an unconstitutional ban,” said Eugene Davidovich, chair of San Diego Americans for Safe Access.
For more information, you can visit the Safe Access IB campaign website or contact the campaign directly at email@example.com, telephone 619-755-2093.