WASHINGTON - As the Joint Select Committee on Deficit Reduction works to adopt deficit reduction measures, Senators Herb Kohl and Chuck Grassley are urging the panel to include a bipartisan bill that cuts costs by encouraging competition from generic drugs.

The Preserve Access to Affordable Generic Drugs Act (S. 27) would deter "pay-for delay" settlements in which brand name drug companies settle patent disputes by paying generic drug manufacturers in exchange for the promise of keeping the generic version of the drug off the market. Under the bill, these anti-consumer pay-off agreements would be presumed illegal and the Federal Trade Commission (FTC) would be given the authority to stop the agreements.

"Keeping generic drugs out of the market costs taxpayers and consumers billions of dollars," Kohl said. "By ending these kinds of backroom deals, generic drugs will get to market sooner and prescription drug costs will go down."

"The wheeling and dealing that these companies take part in only hurts the pocketbooks of taxpayers.  Our bill is a win-win for both the federal government and the consumer.  It won't solve our fiscal problems, but every little bit helps," Grassley said.

The Congressional Budget Office estimated that the bill would save the federal government - which pays approximately one-third of all prescription costs - $2.68 billion over ten years. The president included a provision to end pay-for-delay settlements in his FY 2012 budget and estimated it would save the federal government $8 billion over ten years. The FTC estimated that ending these settlements would save consumers, who pay for prescription drugs through private insurance or on their own, $3.5 billion per year.

The text of the letter is included below and a copy of the letter can be found here.

October 13, 2011

 

The Honorable Patty Murray

Co-Chairman

Joint Select Committee on Deficit Reduction

United States Congress

Washington, DC 20510

 

The Honorable Jeb Hensarling

Co-Chairman

Joint Select Committee on Deficit Reduction

United States Congress

Washington, DC 20510

 

Dear Senator Murray and Representative Hensarling:

As the Joint Select Committee on Deficit Reduction considers measures to accomplish deficit reduction, we urge you to include our bipartisan  pro-consumer legislation to remove barriers to generic drug competition, the Preserve Access to Affordable Generics Act, S. 27.  Because it would increase the availability of low cost generic drugs to millions of Americans, this legislation has been scored by the Congressional Budget Office as saving the federal government over $ 2.68 billion in reduced drug reimbursement payment in federal health programs over the next decade.    The President's budget for FY 2012 estimated that adoption of our bill would save the federal government $ 8.79 billion over the next decade.

Our bill would presume illegal so-called "pay for delay" pharmaceutical patent settlements.   In these settlements, brand name pharmaceutical companies pay millions of dollars in cash or other valuable consideration to generic drug companies to settle drug patent litigation, in return for the generic drug company agreeing to withhold marketing its generic drug until the end, or shortly before, the expiration of the patent.

These pay for delay settlements deprive consumers of years of generic drug competition, while enriching both the generic drug company and the brand name manufacturer, which maintains its monopoly on the drug.   However, consumers lose by paying substantially higher prices and the government loses by paying substantially higher drug reimbursement payments under Medicare and other federal health programs.

In the late 1990s, the FTC challenged several pay-for-delay agreements as being anti-competitive and shortly thereafter, the use of these agreements declined.  From 2000 to 2004, patent cases continued to settle, but the settlements did not include payments to generic drug makers.  Since 2005, however, three Circuit Courts of Appeal decisions have rejected these antitrust challenges, and held that the rights of patent holders make virtually any patent settlement permissible, even anti-competitive settlements, trumping antitrust law.  And the effects of these court decisions were immediate - the FTC found that half of the settlements made in 2006 and 2007 between brand name and generic companies included a pay-off from the brand name manufacturer in exchange for a promise from the generic company to delay entry into the market.  These precedents have made it very difficult for the FTC to successfully challenge these pay-for-delay patent settlements.  Our legislation would ensure that these anticompetitive pay-for-delay agreements are properly subject to antitrust scrutiny.

The Preserve Affordable Access to Generics Act is a balanced solution to addressing this problem.  Under our legislation, these pay-for-delay agreements will be presumed illegal and the FTC will have to pursue legal action under the FTC Act to invalidate a settlement.  During the proceeding, the drug companies will have the opportunity to prove to a judge by clear and convincing evidence that these agreements are pro-competitive.  Significant penalties may be assessed against companies that enter into agreements which are found to be illegal.  This legislation will therefore prevent anti-competitive pay-for-delay agreements while permitting settlements which truly do not harm competition.

In addition, we should stress that our bill would in no way prevent pharmaceutical patent settlements that do not contain pay for delay provisions.   In FY 2010, the FTC reviewed 113 settlements agreements under the Medicare Modernization Act.  Of those, 31 contained pay-for-delay provisions, of which 22 involved different drugs for a total of $9.3 billion in U.S. sales.  The 81 remaining settlements did not have a pay-for-delay provision in them.  This data suggests that these cases can be settled without resorting to a pay-for delay agreement.   Our legislation only targets those settlements that harm competition - pay-for-delay agreements in which cash or other valuable consideration is exchanged for delay in generic entry.

 

Our legislation passed the Senate Judiciary Committee with bipartisan support in both of the last two Congresses, most recently in July.   By removing a significant barrier to the availability of generic drugs, this bill will reduce the federal deficit and benefit millions of consumers. We urge the Joint Select Committee to include our bill as part of any overall deficit reduction measure that you adopt.

Thank you for your consideration.

Sincerely,

 

 

_____________________________ 

HERB KOHL                           CHUCK GRASSLEY                      

Chairman, Subcommittee on                   Ranking Member, Committee on the

Antitrust,  Competition Policy                    Judiciary

and Consumer Rights

 

 

CC:

Senator Max Baucus

Senator John Kerry

Senator Jon Kyl

Senator Rob Portman

Senator Pat Toomey

Congressman Xavier Becerra

Congressman Dave Camp

Congressman James Clyburn

Congressman Fred Upton

Congressman Chris Van Hollen

MILWAUKEE, WI - With busy schedules full of work, sports, and other activities, it can be difficult to get the family together for a meal.  October is National Eat Better, Eat Together Month, an opportunity for families to start new traditions, make time for one another, and eat healthy.  TOPS Club, Inc. (Take Off Pounds Sensibly), the nonprofit weight loss support organization, provides ideas to make time for family meals and reap the rewards.

Enjoy the benefits

According to Martha Marino, M.A., RD, CD, and Sue Butkus, Ph.D., RD, of Washington State University and The Nutrition Education Network of Washington, there are many benefits of eating together.

• Family dinners promote healthy eating habits and are an ideal opportunity for parents to teach their children about nutrition and demonstrate healthy practices.  Kids who regularly eat with their families tend to consume more fruits and vegetables rather than junk food.  Parents can also broaden their children's horizons and introduce new foods during family meals.

• Time together can open the lines of communication between parents and children and help form stronger, healthier relationships.  Family members have a chance to share details about their day, plan, learn about one another, and more.  Table talk also allows children to express ideas and learn new vocabulary from adults' conversations.

• Studies show that eating together can contribute to higher academic performance and improved well-being.  The stability of family meals and conversation are essential for kids as they develop and learn.

• Food dollars can go further with large, homemade meals, rather than fast food or individual dishes.  Cooking one meal and preparing food in advance also saves time in the kitchen.

Put it on the calendar

The calendar fills up quickly, especially as kids get older.  It's important to make family time a priority and set a schedule that will work for everyone.  If there is only one day that works for each person, make it a weekly habit and work up to two or three times each week, if you can.  Breakfast and lunch count as meals, so don't limit family time to dinner.

Prepare meals ahead

To avoid falling into the common excuse that everyone's schedule is too hectic, make meals ahead of time.  Weekends are a great opportunity to compile a shopping list, purchase groceries, and prepare weekday meals.  If you have extra time, cook double servings and put the extra food in the freezer, to be used as a backup for busy nights.

Get the children involved

It's important to engage the kids and have them participate.  Give them the opportunity to provide input on what is served or assign tasks - setting the table, washing the produce, pouring beverages, and mixing ingredients.  Teenagers could even cook one of the meals.

Make it fun

Want to make meals more interesting?  There are many creative ideas that can keep family time exciting.

• Move it outdoors and have a picnic.

• Turn off the television, cell phones, and the computer and have a conversation.  Go around the table and talk about the highs and lows of everyone's day and ask each other questions.

• Plan a theme for different meals - fiesta, dinner and a movie, fondue party, build your own burger or pizza, "favorites meal" (making each family member's preferred dish), and more.

• Take turns planning the meals.  One night Mom or Dad can arrange dinner, and the kids can prepare breakfast another day.  This will get everyone involved with meal planning, and it will give family members an opportunity to be creative.

• Dress up the dinner table, making the occasion seem special.  Use candles, table clothes, fancy dishes, or props for a themed dinner.

TOPS Club Inc. (Take Off Pounds Sensibly) is the original weight-loss support and wellness education organization.  Founded more than 63 years ago, TOPS is the only nonprofit, noncommercial weight-loss organization of its kind.  TOPS promotes successful weight management with a "Real People. Real Weight Loss." philosophy that combines support from others at weekly chapter meetings, healthy eating, regular exercise, and wellness information.  TOPS has about 170,000 members - male and female, age seven and older - in nearly 10,000 chapters throughout the United States and Canada.

Visitors are welcome to attend their first TOPS meeting free of charge.  Membership is affordable at just $26 per year, plus nominal chapter fees.  To find a local chapter, view www.tops.org or call (800) 932-8677.

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Grassley Questions Agency on Decision to Shut Down Public File on Disciplined Doctors

WASHINGTON - Sen. Chuck Grassley of Iowa today asked the head of a federal agency to explain a decision to shut down public access to data on malpractice payouts, hospital discipline and regulatory sanctions against doctors and other health professionals.  The public data file did not include doctors' names, only data that would allow journalists and analysts to track trends in disciplinary actions.  The Health Research and Services Administration shut down the public file after a newspaper reporter used the publicly available information to track down the identity of a doctor who had a long record of malpractice cases against him but was never disciplined by the state.

"Shutting down public access to the data bank undermines the critical mission of identifying inefficiencies within our health care system - particularly at the expense of Medicare and Medicaid beneficiaries," Grassley wrote in his letter to the agency.  "More transparency serves the public interest. Generally speaking, except in cases of national security, the public's business ought to be public.  Providers receive billions of dollars in state and federal tax dollars to serve Medicare and Medicaid beneficiaries. Accountability requires tracking how the money is spent."

The text of Grassley's letter is available here.   More information on how journalists have used the public database to inform the public is available here.

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MILWAUKEE, WI - Spices and herbs can give a boost of flavor to any meal, but they also have health benefits.  With increasing interest in "functional food," herbs and spices have been receiving greater attention for their potential to decrease inflammation, reduce the risk of cancer, fight heart disease, and more.  TOPS Club, Inc. (Take Off Pounds Sensibly), the nonprofit weight-loss support organization, along with the International Food Information Council (IFIC), explains how different spices can benefit people who are on their own wellness journey.

Basil

Basil can give a fresh flavor to any pizza or pesto, but this spice is more than just a seasoning.  Basil has anti-inflammatory properties, which can help prevent swelling and alleviate pain caused by arthritis.  It also contains the flavonoids orientin and vicenin that can shield a person's cells from radiation and other damage.  Have a cut or scrape?  Basil has strong antibacterial capabilities and can help prevent infections.

Cinnamon

Cinnamon has a subtle heat that is perfect for baked treats and warm beverages.  Significant attention is being directed toward its potential in diabetes management.  Research suggests that cinnamon may lower blood glucose levels, increase insulin sensitivity, and improve lipid profiles.  Also, the sweet aroma of cinnamon has been shown to boost brain function.

Parsley

Parsley adds flavor and color to meals and is a source of vitamins A, C, and K.  It also has antioxidants and can aid heart and optimal health.

Mint

Found in tea, ice cream, toothpaste, and more, mint is a versatile flavor.  Containing vitamins A and C, mint has antioxidants and can help decrease the risk of cancer.  It can soothe an upset stomach, relieve heartburn, loosen congestion, and help calm.  Let's not forget that mint can also keep a person's breath fresh!

Cilantro

Cilantro is delicious in salsa, guacamole, and salads and has numerous health benefits.  It contains anti-inflammatory properties, is a good source of iron, magnesium, and manganese, and can control blood sugar and cholesterol.  Research shows that it also can help battle salmonella bacteria.

Garlic

Garlic has anti-inflammatory, antibacterial, and antiviral capabilities.  It also can lower cholesterol and the risk of cancer and contains vitamins B6 and C, which fight heart disease.

Red and Chili Pepper

An increase in body temperature or heart rate upon ingestion of a pepper is believed to increase metabolism.  Red peppers contain capsaicin, which accelerates energy expenditure and increases lipid oxidation.  Studies also suggest that consuming capsaicin decreases fat intake.  Chili peppers can fight inflammation and help relieve pain.

Ginger

Ginger provides gastrointestinal and nausea relief.  Recent studies also suggest that ginger may play a role in preventing inflammation, which could be useful in alleviating pain caused by arthritis.  Ginger plays a potential role in cancer prevention with its antioxidant properties.  Its immunity boosting capabilities is another advantage.

Turmeric (Curcumin)

Turmeric, a popular spice contained in curry powder, contains curcumin.  Curcumin gives turmeric its yellow pigment and may reduce the risk of cancer, osteo- and rheumatoid arthritis, and Alzheimer's disease.  It also has antioxidant properties.

TOPS Club Inc. (Take Off Pounds Sensibly), the original, nonprofit weight-loss support and wellness education organization, was established more than 63 years ago to champion weight-loss support and success.  Founded and headquartered in Milwaukee, Wisconsin, TOPS promotes successful, affordable weight management with a philosophy that combines healthy eating, regular exercise, wellness information, and support from others at weekly chapter meetings. TOPS has about 170,000 members in nearly 10,000 chapters throughout the United States and Canada.

Visitors are welcome to attend their first TOPS meeting free of charge. To find a local chapter, view www.tops.org or call (800) 932-8677.

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