user: Input: A Bipartisan Senate Bill Wants to Help Generic Drug Makers
Four U.S. senators – two Democrats and two Republicans – introduced a bill on Tuesday aimed at preventing big pharmaceutical companies from using safety rules to prevent generic drugs from coming to market.

Senators Charles Grassley, chair of the Judiciary Committee, and Patrick Leahy, the top Democrat, are sponsors of the bill along with Senators Mike Lee and Amy Klobuchar, the chair of the antitrust subcommittee and top Democrat, respectively.

The Food and Drug Administration, which ensures the safety of the country’s food and drug supply, has a risk evaluation and mitigation strategy program, called REMS, which is designed to ensure that the riskiest drugs are dispensed safely.

But there have been complaints that the program has been misused by brand-name drug companies to prevent generic manufacturers from getting the drug samples needed to market cheaper versions. Generic companies also complain their drugs are not allowed to share a safety protocol, making it difficult to come to market.

The bill would allow a generic manufacturer who faces either of these situations to file a lawsuit to force access to a sample or force negotiations for a safety protocol.

“Balancing the cost of developing lifesaving medications with the need to make available affordable prescription drugs to consumers has always been a difficult task. It’s a consistent topic at my town meetings,” Grassley said in a statement.

“Unfortunately, we’re seeing some brand-name drug companies engage in anti-competitive tactics that delay entry of lower cost generic drugs into the market. This bill takes important steps to ensure that our laws are not frustrated.”

There is a similar bill in the House of Representatives which addresses the same issue but uses a different strategy. For example, it requires the generic company seeking a REMS drug to get FDA authorization to obtain the sample.

In one of the REMS disputes which is public, Mylan Pharmaceuticals filed a lawsuit in 2014 against Celgene Corp , accusing it of using REMS to prevent generic copies of Thalomid and Revlimid to market.

The Senate Judiciary Committee’s antitrust panel will hold a hearing on its bill on June 21.

The Pharmaceutical Research and Manufacturers of America, or PhRMA, which counts major drugmakers among its members, said it had no immediate comment.

The Generic Pharmaceutical Association was pleased to see the bill introduced.

“It is worth noting and recognizing recent efforts by representatives in the branded industry to highlight the valuable role generic medicines play in driving healthcare system savings,” said Chip Davis, GPhA’s president. “Continued use of these anticompetitive practices by certain manufacturers drives the exact opposite outcome.”
What was this article about?
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It's about: Their bill would give generic makers more power.


Problem: Gay Marriage Ban Overturned in Pennsylvania

A federal judge in Pennsylvania overturned the state’s ban on gay marriage Tuesday, the latest in a flurry of rulings that, if upheld, will make same-sex unions legal across the entire northeast United States.

Eleven couples and the American Civil Liberties Union filed the case in 2013, saying the law harmed them by denying them legal protections and tax benefits afforded to same-sex married couples.

“Loving and committed couples and their families in the nation’s sixth largest state will be able to share in the joy, security and dignity that come with the freedom to marry,” Evan Wolfson, president of Freedom to Marry, said in a statement. “The stone that was once left out has become the keystone, and now it’s time to finish the job nationwide.”

Republican Gov. Tom Corbett is likely to appeal the ruling. His office had taken up defense of the ban after Attorney General Kathleen Kane, a rising-star Democrat, declined to defend it in court, calling it unconstitutional and citing the Supreme Court’s ruling striking down part of the federal Defense of Marriage Act.

Kane said she stands by her decision to refuse to defend the law, and celebrated the judge’s ruling Tuesday

“Today brings justice to Pennsylvanians who have suffered from unequal protection under the law because of their sexual orientation,” she said in a statement. “When state-sponsored inequality exists, citizens are deprived of the full protections that the Constitution guarantees. Our Commonwealth progressed today and so have the hopes and dreams of many who suffer from inequality.”

A recent poll found that 56 percent of Pennsylvanians support same-sex marriage.

Write a one or two sentence summary.

Summary: Gay marriage is now legal across the northeast


Q: Freddie Prinze Jr. launches first cookbook, joins bevy of celebs finding fame in the kitchen

Fans of mid-1990s rom-coms rejoice.

Freddie Prinze, Jr. is back. But not on the big screen. This time the former teen heartthrob is melting cheese-- instead of hearts—in the kitchen.

“Back to the Kitchen,” the actor’s first cookbook was released Tuesday, making him the latest celebrity to pivot his onscreen career to cooking.

Prinze Jr. doesn’t claim to be a professional chef but his love of cooking developed at an early age. In the intro, the actor explains that he “didn't learn how to throw a football until I was out of high school, so no chance of playing in the Super Bowl for me [...] My mom said the kitchen was a better place for my brainy-brain, and plus, she wasn't into sports."

So what does the actor like to whip up at home?

According to Amazon, since Prince Jr. pays homage to Puerto Rican heritage and the flavors of his hometown in New Mexico.

“His eggs come New Mexico style, served with from-scratch biscuits and green-chile gravy. His tacos are the real deal: soft tortillas, homemade salsa, filled with steak layered with quick-pickled cucumbers, or spicy fish dressed with watermelon and thai chiles. Now in this family-focused cookbook, Freddie teaches fans to cook his mainstays, the recipes that he makes on even the busiest weeknights, as well as more luxurious date night meals.”

Prinze Jr.’s book may have plenty of spice but he’s not the first in the family to dabble in the culinary world. Last fall, wife Sarah Michelle Gellar launched Food Stirs, a Blue Apron-type subscription service focused on everyone’s favorite part of dinner: desserts.

"Back to the Kitchen" includes 75 recipes and personal anecdotes from the actor. The hardcover version retails for $17.79 on Amazon.

A:

assistant: The actor’s wife has a line of baking kits.