 |
|
February 22, 2012
Warren Richey: How Supreme Court ruling on Texas could reduce affirmative action across US
Philip Moeller: Hard time determining your current and future savings needs --- and even harder still, executing a plan? Here's what to do about it!
Menachem Wecker: In Tough Job Market, Law Grads Use J.D.s for Nonlegal Work
February 21, 2012
Michael Doyle: Supreme Court to hear arguments on whether a lie is protected speech
Neela Banerjee: NSC wants rules on research that could lead to biological weapons
Fred Weir: Fearing West, Putin pledges biggest military buildup since cold war
February 17, 2012
Kristen Chick: After surviving sectarian mob, Egyptian Christians expelled from village
Eryn Brown: Microchip is a new means of medicating
February 16, 2012
SeaWorld of Pain : Watch Wyatt Cenac, a black comic, confront "whale freedom rider" Lisa Lange of PETA and make her squirm ( LENGTH: 5 minutes)
Jason Koebler: Antibiotics Do Nothing to Cure Sinus Infections, Study Says
February 15, 2012
Jeffrey Fleishman: Women were at the vanguard in the protests that ousted Hosni Mubarak. Meet some who refuse to wake up from their dream --- the mullahs and military be damned
Richard Simon: 'The check is in the mail' could soon be a legal excuse
Liz Bowie: Debate on whether cursive writing should still be taught
Jason Koebler: Super Plants: Could Re-Wired Plants Be the New Cancer Killers?
Susan Johnston: Strategies to preempt unwanted calls or other communication from collectors
February 14, 2012
Dennis Prager: Chris Christie on Israel --- and What It Means to Be a Leader
Frank J. Gaffney Jr.: Shariah's police? Interpol's honoring of Saudi warrant could lead to arrest of Americans
The Kosher Gourmet by Matt Armendariz: VEGETABLE CRUMBLE is a simple, satisfying dish of tender eggplant, zucchini, tomatoes and onions crowned with a savory buttery topping and a sprinkle of fresh herbs
February 13, 2012
Binyamin Rose: Back to the Bunker: How a life-risking act by a Christian family during the Holocaust saved a family and built a thriving community a world away
Menachem Wecker: Business Schools Teach Real Estate Despite Troubled Housing Market
February 10, 2012
Lisa M. Krieger: Man with defibrillator demands access to his own heart's information
David G. Savage: Why activists may not be in a hurry to have High Court rule on alternative marriage
February 9, 2012
Laura McMullen: 10 Least Expensive Public Schools for Out-of-State Students
Kimberly Palmer: How to actually enjoy -- relaxing, financially -- your vacation
February 8, 2012
Warren Richey: Why momentous Prop. 8 ruling might not satisfy gay-rights groups
Menachem Wecker: Though Controversial, LL.M.'s Can Lead to Specialized Legal Jobs
The Kosher Gourmet byDana Velden: Going to the bother of making soup? You know it better be good. This CREAM OF TOMATO SOUP certainly is! And it's a cinch to make, too (Includes techinques and serving secrets)
February 7, 2012
Frank J. Gaffney, Jr.: Caught off-guard? President's Super Bowl interview with Matt Lauer gives those who need a reason not to vote for him, a darn good one
Suzanne Bohan: Leaping lizards! Tiny reptiles advancing robot design
February 6, 2012
Jonathan Tobin: Iran Threatens Israel With Destruction, But the New York Times Doesn't Hear It
Jeffrey Fleishman: In newly democratic Egypt, tens of democracy activists jailed, to stand trial; their groups are 'threatening the stability of the homeland'
Julie Deardorff : Researchers say antioxidants may not be that effective and could do more harm than good
Mark Clayton: How did Anonymous hackers eavesdrop on FBI and Scotland Yard?
February 3, 2012
Edmund Sanders : Israeli official says Iran is creating missile that could reach East Coast of US
Victoria Kim: Immigrant-smuggling ring used black drivers to avoid racial profiling
February 2, 2012
Jim Carney: Wrong number call may have saved her life
Reza Kahlili : Ex-CIA spy in Iran's Revolutionary Guard: What Obama doesn't grasp about striking deals with Tehran
Tina Susman: For woodchuck rescuer, every day is Groundhog Day
February 1, 2012
Brian Bennett: US officials see increasing threat of domestic attack from Iran
Emily Brandon: How to Take Advantage of New 401(k) Fee Disclosures
January 31, 2012
January 30, 2012
Paul Richter and Ramin Mostaghim: Misreading Teheran's limits -- deadly and economically devastating as they may be -- is a risk administration, Europe seem willing to take
Suzanne Bohan: Warning: Nap-deprived tots missing more than sleep, study finds
Meg Handley: Banks Revamping Rewards Programs to Woo Customers
January 27, 2012
Caroline B. Glick: Obama: Of course I intend to prevent a nuclear holocaust . . . in a few months
Yochonon Donn: In liberal New York City, fervently-Orthodox Jews may soon be getting a district to call their own
Jeannine Stein: An inflated ego and thinking you're 'all that' doesn't just make others sick of you, it can make you ill
Katy Hopkins: New budget rules may affect how much money you get for college
January 26, 2012
Ed Koch: To the New York Times, calling for the murder of Jews by those capable of having their incitement taken seriously isn't news
Jeannine Stein: Mental illness struck one in five U.S. adults in 2010: Report
January 25, 2012
Richard Simon: House passes two bills endorsing the use of religious symbols at military memorials
Fred Weir: Putin: Multiethnic Russia cannot survive as a US-style 'melting pot'; must find its own way
Susan Johnston: 5 Sneaky Coupon Strategies Consumers Should Watch Out For
January 24, 2012
Carol Clark: The price of your soul: How your brain decides whether to 'sell out'
Caroline B. Glick: America lost most in 'Arab Spring'. Sadly, many voters still don't grasp the extent
Warren Richey: Drug criminal scores win in GPS ruling from conservative-leaning high court
Erika Bolstad: Black conservatives gather to talk about gaining strength
January 23, 2012
Melissa Dribben: Jewish voters to play a key role in Florida's Republican primary
Jordan Rau: In quest to grow, Catholic hospital system will announce this morning its break from church
Ali Safi: U.S. envoy gives Taliban terms for peace talks
January 19, 2012
January 18, 2012
January 17, 2012
Frank J. Gaffney Jr.: No-kidding red lines: U.S. response to an Iranian nuke may be bluster, but Israel's won't be
David G. Savage: They sued their principals after slandering them online --- now the cases are headed to the Supreme Court
David Francis: Where to Invest in 2012: With stocks expected to rebound, opportunity abounds for investors
January 13, 2012
Ben Lynfield: Israeli lawmakers move to annex Jewish Judea, one museum at a time
Alexia Elejalde-Ruiz: Thriving through touch: Gentle massage helps older people with low mobility improve in mind and body
January 12, 2012
Warren Richey: Landmark Supreme Court ruling a 'resounding win' for religious groups
Warren Richey: Supreme Court says no to new rule on eyewitness testimony
John Fauber : Statins found to raise diabetes risk in postmenopausal women
Katy Hopkins : Consider This Before You Pay for an Online Degree
The Kosher Gourmet by Joseph Erdos: This mushroom and barley soup has an intense -- almost nutty -- flavor that mixes robust with Middle East. It has creaminess without cream
January 11, 2012
Shari Roan: Millions of atrial fibrillation sufferers at risk for devastating, but preventable, stroke
Tom Hussain: Pakistan -- recipient of more than $21 billion in civilian and military aid -- speeds pursuit of Iranian pipeline, defying US
David G. Savage: High court signals it won't be loosening TV's 'indecency' rules
Stephen Ceasar: Oklahoma's Islamic law amendment can't go into effect, court rules
January 10, 2012
Reza Kahlili: From an ex-CIA spy: US must exploit new split in Iran's Revolutionary Guard
Karen Kaplan: Study: Nicotine replacement products ineffective when used in real-life situations
January 9, 2012
Michael Doyle: Put through legal hell over dream home, couple fought back hard --- all the way to Supreme Court
|
| |
Jewish World Review
FDA moves to undercut huge price increase by pregnancy drug maker
By
Andrew Zajac
| 
|
|
|
| |
|
http://www.JewishWorldReview.com | (MCT)
The Food and Drug Administration took the unusual step Wednesday of inviting pharmacies to make a legal end run around a St. Louis company that obtained agency approval for a pregnancy drug and promptly raised the price from $20 per dose to $1,500.
The drug, a synthetic form of progesterone trade named Makena, is recommended for women at high risk of delivering prematurely. And the price increase K-V Pharmaceutical Co. ignited a firestorm of objections from patients, political leaders and medical organizations.
Now, the FDA has declared it will not take enforcement action against pharmacies that fill prescriptions for the drug by compounding their own versions instead of using the version marketed by K-V.
The problem arises out of an unusual situation. Until early this year, women obtained the drug from so-called compounding pharmacies that produced it on a made-to-order basis.
Although custom-made for each patient, it had been priced at only about $20 per dose.
Then last February, K-V was granted exclusive rights for seven years to make Makena, ending, at least in theory, the need for made-to-order versions.
But the company's pricing announcement, coupled with letters K-V sent to pharmacies warning them of possible FDA enforcement action if they kept compounding the drug, aroused a strong push back from several members of Congress, including Sens. Sherrod Brown, D-Ohio, and Amy Klobuchar, D-Minn., as well as from patients and obstetrical and pediatric groups.
| FREE SUBSCRIPTION TO INFLUENTIAL NEWSLETTER |
| Every weekday JewishWorldReview.com publishes what many in the media and Washington consider "must-reading". HUNDREDS of columnists and cartoonists regularly appear. Sign up for the daily update. It's free. Just click here. | |
Many complained that the huge cost increase was an unfair burden on patients, private insurers and Medicaid programs, which already are buckling as state budgets crumble in the face of a bad economy and declining revenues.
Responding to the public and political pressure, the FDA said it had no intention of blocking pharmacies from selling their own versions of Makena.
"In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound (Makena) based on a valid prescription," the statement said.
The agency noted that K-V "received considerable assistance from the federal government in connection with the development of Makena by relying on research funded by theNational Institutes of Health to demonstrate the drug's effectiveness."
K-V shares lost 20 percent of their value Wednesday, closing at $5.65, down $1.46.
In a statement after the FDA's announcement, K-V said it would do more to make the drug affordable, though it did not say it would lower the price.
"Based on feedback the company has received, we are currently exploring additional ways to help provide affordable access for all patients who are prescribed Makena," the statement said.
Makena is administered in weekly injections, usually beginning at between 16 to 18 weeks into a pregnancy and continuing until 36 weeks.
K-V's pricing increased the cost of the drug to $30,000 from about $400 for that time period.
K-V's Makena application was approved under the Orphan Drug Act, which gives drugs needed by relatively small populations of patients expedited evaluation and confers seven years of protection from generic competition.
But the protection from competition does not include compounding pharmacies, whose products are not FDA-approved.
"Orphan drug exclusivity only prevents approval of another application for the same indication. Pharmacy compounding is not done under an approved application," said FDA spokesman Jeffrey Ventura.
FDA has the authority to crack down on compounding pharmacies when they offer products that compete with FDA-approved drugs, but is not obligated to do so.
Without making the comparison explicit, K-V's statement seemed to draw a contrast between Makena's status as an FDA-blessed compound and the non-approved products of compounding pharmacies.
Its one-page statement mentioned some variant of "FDA" or "FDA-approved" a dozen times.
"It's a non-issue," said James Moran, Chair of OB/GYN Department at Saint John's Health Center in Santa Monica, Calif. "There are plenty of really good compounding pharmacies we deal with all the time."
Since 2003, the American Congress of Obstetricians and Gynecologists has recommended that Makena be offered to high-risk women — those who have had at least one previous preterm delivery.
An estimated 500,000 babies are born prematurely in the U.S. each year, and those births are associated with a range of health and developmental problems, as well as with billions of dollars in additional medical costs.
Interested in a private Judaic studies instructor — for free? Let us know by clicking here.
Every weekday JewishWorldReview.com publishes inspirational material. Sign up for the daily JWR update. It's free. Just click here.
We want your comments! Please let us know what you think by clicking here.
© 2011, Tribune Co.. Distributed by McClatchy-Tribune Information Services.
|
