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December 2, 2014

Jonathan Tobin: Defending the Right to a Jewish State

Heather Hale: Compliment your kids without giving them big heads

Megan Shauri: 10 ways you are ruining your own happiness

Carolyn Bigda: 8 Best Dividend Stocks for 2015

Kiplinger's Personal Finance editors: 7 Things You Didn't Know About Paying Off Student Loans

Samantha Olson: The Crucial Mistake 55% Of Parents Are Making At Their Baby's Bedtime

Densie Well, Ph.D., R.D. Open your eyes to yellow vegetables

The Kosher Gourmet by Megan Gordon With its colorful cache of purples and oranges and reds, COLLARD GREEN SLAW is a marvelous mood booster --- not to mention just downright delish
April 18, 2014

Rabbi Yonason Goldson: Clarifying one of the greatest philosophical conundrums in theology

Caroline B. Glick: The disappearance of US will

Megan Wallgren: 10 things I've learned from my teenagers

Lizette Borreli: Green Tea Boosts Brain Power, May Help Treat Dementia

John Ericson: Trying hard to be 'positive' but never succeeding? Blame Your Brain

The Kosher Gourmet by Julie Rothman Almondy, flourless torta del re (Italian king's cake), has royal roots, is simple to make, . . . but devour it because it's simply delicious

April 14, 2014

Rabbi Dr Naftali Brawer: Passover frees us from the tyranny of time

Greg Crosby: Passing Over Religion

Eric Schulzke: First degree: How America really recovered from a murder epidemic

Georgia Lee: When love is not enough: Teaching your kids about the realities of adult relationships

Cameron Huddleston: Freebies for Your Lawn and Garden

Gordon Pape: How you can tell if your financial adviser is setting you up for potential ruin

Dana Dovey: Up to 500,000 people die each year from hepatitis C-related liver disease. New Treatment Has Over 90% Success Rate

Justin Caba: Eating Watermelon Can Help Control High Blood Pressure

The Kosher Gourmet by Joshua E. London and Lou Marmon Don't dare pass over these Pesach picks for Manischewitz!

April 11, 2014

Rabbi Hillel Goldberg: Silence is much more than golden

Caroline B. Glick: Forgetting freedom at Passover

Susan Swann: How to value a child for who he is, not just what he does

Cameron Huddleston: 7 Financial Tasks You Should Tackle Right Now

Sandra Block and Lisa Gerstner: How to Profit From Your Passion

Susan Scutti: A Simple Blood Test Might Soon Diagnose Cancer

Chris Weller: Have A Slow Metabolism? Let Science Speed It Up For You

The Kosher Gourmet by Diane Rossen Worthington Whitefish Terrine: A French take on gefilte fish

April 9, 2014

Jonathan Tobin: Why Did Kerry Lie About Israeli Blame?

Samuel G. Freedman: A resolution 70 years later for a father's unsettling legacy of ashes from Dachau

Jessica Ivins: A resolution 70 years later for a father's unsettling legacy of ashes from Dachau

Kim Giles: Asking for help is not weakness

Kathy Kristof and Barbara Hoch Marcus: 7 Great Growth Israeli Stocks

Matthew Mientka: How Beans, Peas, And Chickpeas Cleanse Bad Cholesterol and Lowers Risk of Heart Disease

Sabrina Bachai: 5 At-Home Treatments For Headaches

The Kosher Gourmet by Daniel Neman Have yourself a matzo ball: The secrets bubby never told you and recipes she could have never imagined

April 8, 2014

Lori Nawyn: At Your Wit's End and Back: Finding Peace

Susan B. Garland and Rachel L. Sheedy: Strategies Married Couples Can Use to Boost Benefits

David Muhlbaum: Smart Tax Deductions Non-Itemizers Can Claim

Jill Weisenberger, M.S., R.D.N., C.D.E : Before You Lose Your Mental Edge

Dana Dovey: Coffee Drinkers Rejoice! Your Cup Of Joe Can Prevent Death From Liver Disease

Chris Weller: Electric 'Thinking Cap' Puts Your Brain Power Into High Gear

The Kosher Gourmet by Marlene Parrish A gift of hazelnuts keeps giving --- for a variety of nutty recipes: Entree, side, soup, dessert

April 4, 2014

Rabbi David Gutterman: The Word for Nothing Means Everything

Charles Krauthammer: Kerry's folly, Chapter 3

Amy Peterson: A life of love: How to build lasting relationships with your children

John Ericson: Older Women: Save Your Heart, Prevent Stroke Don't Drink Diet

John Ericson: Why 50 million Americans will still have spring allergies after taking meds

Cameron Huddleston: Best and Worst Buys of April 2014

Stacy Rapacon: Great Mutual Funds for Young Investors

Sarah Boesveld: Teacher keeps promise to mail thousands of former students letters written by their past selves

The Kosher Gourmet by Sharon Thompson Anyone can make a salad, you say. But can they make a great salad? (SECRETS, TESTED TECHNIQUES + 4 RECIPES, INCLUDING DRESSINGS)

April 2, 2014

Paul Greenberg: Death and joy in the spring

Dan Barry: Should South Carolina Jews be forced to maintain this chimney built by Germans serving the Nazis?

Mayra Bitsko: Save me! An alien took over my child's personality

Frank Clayton: Get happy: 20 scientifically proven happiness activities

Susan Scutti: It's Genetic! Obesity and the 'Carb Breakdown' Gene

Lecia Bushak: Why Hand Sanitizer May Actually Harm Your Health

Stacy Rapacon: Great Funds You Can Own for $500 or Less

Cameron Huddleston: 7 Ways to Save on Home Decor

The Kosher Gourmet by Steve Petusevsky Exploring ingredients as edible-stuffed containers (TWO RECIPES + TIPS & TECHINQUES)

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.


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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.

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