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FDA lowers age for buyers of Plan B pill to 15

WASHINGTON — In a surprise twist to the decade-plus effort to ease access to morning-after pills, the government is lowering the age limit to 15 for one brand — Plan B One-Step — and will let it be sold over the counter.

Today, Plan B and its generic competition are sold behind pharmacy counters, and people must prove they're 17 or older to buy the emergency contraception without a prescription. A federal judge had ordered an end to those sales restrictions by next Monday.

But Tuesday, the Food and Drug Administration approved a different approach: Plan B could sit on drugstore shelves next to condoms, spermicides or other women's health products — but to make the purchase, buyers must prove they're 15 or older at the cash register.

Manufacturer Teva Women's Health, which had applied for the compromise path, said it planned to make the switch in a few months.

The question is whether Tuesday's action settles the larger court fight. Earlier this month, U.S. District Judge Edward Korman of New York blasted the Obama administration for imposing the age-17 limit, saying it had let election-year politics trump science and were making it hard for women of any age to obtain emergency contraception in time for it to work.

The FDA said Tuesday's decision was independent of the court case and wasn't intended to address it. The Justice Department remained mum on whether it planned to appeal Korman's ruling by Monday's deadline, and the White House had no immediate comment.

The women's group that sued over the age limits said Tuesday's action is not enough, and it will continue the court fight if necessary.

Lowering the age limit "may reduce delays for some young women but it does nothing to address the significant barriers that far too many women of all ages will still find if they arrive at the drugstore without identification," said Nancy Northup, president of the Center for Reproductive Rights.

The FDA said the Plan B One-Step will be packaged with a product code that prompts the cashier to verify a customer's age. Anyone who can't provide such proof as a driver's license, birth certificate or passport wouldn't be allowed to complete the purchase. In most states, driver's licenses, the most common form of identification, are issued at age 16.

"While an improvement over current policy, today's announcement is still disappointing," said Marcia D. Greenberger of the National Women's Law Center. "Because all women will be required to show an ID to establish their age, those without IDs could be denied access."

Other advocates called the move promising. "This decision is a step in the right direction for increased access to a product that is a safe and effective method of preventing unintended pregnancies," said Sen. Patty Murray, D-Wash. "It's also a decision that moves us closer to these critical availability decisions being based on science, not politics."

Social conservatives had opposed any efforts to loosen restrictions on sale of the morning-after pill, arguing that it was important for parents and medical professionals to be involved in such decisions involving young girls.

The group Concerned Women for America charged that health officials were putting politics and so-called progress ahead of the health of children as well as women.

"It makes no sense that kids need parental permission to take aspirin at school, but they're free to buy and administer Plan B," Penny Nance, CEO and president of CWA, said in a statement.

Half the nation's pregnancies every year are unintended, and doctors groups say more access to morning-after pills could cut those numbers. The pills contain higher doses of regular contraceptives and, if taken within 72 hours of unprotected sex, can cut the chances of pregnancy by up to 89 percent. But they work best if taken in the first 24 hours.

The FDA had been poised to lift all age limits and let Plan B be sold over the counter in late 2011, but Health and Human Services Secretary Kathleen Sebelius, in an unprecedented move, overruled her own scientists. Sebelius said some girls as young as 11 are physically capable of bearing children but shouldn't be able to buy the pregnancy-preventing pill on their own.

President Barack Obama supported Sebelius' move and a spokesman said the president's position hadn't changed.

The Justice Department could appeal Korman's ruling and seek a stay. If granted, the appeals process would move through the courts, while Plan B is sold over the counter whenever Teva has the product repackaged to meet the FDA's requirements.

Absent a stay, "we will want to go back to court as quickly as possible and ask the judge to hold them in contempt," said Janet Crepps, a senior counsel for the Center for Reproductive Rights.

The FDA said Tuesday that Teva had provided data proving that girls as young as 15 could understand how Plan B works and use it properly, without the involvement of a health care provider. Teva plans to conduct a consumer-education program and indicated it is willing to audit whether stores are following the age requirement, the agency said.

The FDA said its ruling applies only to Plan B One-Step, and not to generic versions of the pill, which would remain behind pharmacy counters with the age-17 restriction.

If a woman already is pregnant, the morning-after pill has no effect. It prevents ovulation or fertilization of an egg. According to the medical definition, pregnancy doesn't begin until a fertilized egg implants itself into the wall of the uterus. Still, some critics say Plan B is the equivalent of an abortion pill because it may also be able to prevent a fertilized egg from attaching to the uterus, a contention that many scientists — and Korman, in his ruling — said has been discredited.

McDonald's cuts Angus burgers from menu 


McDonald’s is cutting the Angus burger from its menu. (AP Photo/Mike Lee)

NEW YORK — McDonald's is cutting the Angus burger from its menu.

The Oak Brook, Ill.-based company had said earlier this year that it was evaluating whether to continue selling the Angus Third Pounders, which were introduced in 2009 and are among the chain's priciest items. The company also said at the time that it was it was cutting Chicken Selects and Fruit & Walnut Salad.

The changes come as McDonald's looks to keep up with shifting tastes, even as it underscores the affordability of its food. The website BurgerBusiness.com, which reported that the burgers were being dropped earlier Thursday, also said that it learned from McDonald's franchisees that the company intends to expand its line of lower-cost Quarter Pounders in coming months, including an option with bacon.

At a time when the restaurant industry is barely growing, McDonald's has been playing up its Dollar Menu in ads to boost sales and steal customers away from competitors. Even if that hurts profit margins, executives say the strategy is critical to gaining market share and ensuring the long-term health of the company.

But Richard Adams, who consults McDonald's franchisees, said that the Dollar Menu has also made the Angus burger a less attractive option at around $4 to $5.

"When you can get four or five burgers off the Dollar Menu, nobody's going to buy the Angus burger," he said. "The Dollar Menu has become a real problem for these chains."

Another problem was that McDonald's wasn't able to raise prices on the Angus burgers, even as its own costs for beef continued to rise, said Howard Penney, a restaurant analyst with Hedgeye Risk Management. He said the chain didn't have that kind of "pricing power," meaning its customers wouldn't be willing to pay more than a certain amount for its food.

Without elaborating, McDonald's Corp. said in statement Thursday that the Angus burgers "may still play a future role on our menu." It said it was removing the burgers and Angus snack wraps to "make room for new and exciting choices for our customers."

McDonald's did not immediately say whether the burgers and snack wraps were still being sold in some restaurants. But at a McDonald's in a Detroit suburb, a "Product no longer available" sign was stamped on the menu over pictures of the three Angus burgers. Scott Hume, editor of BurgerBusiness.com, noted that Angus burger sales had been soft for some time.

"It gets to the point where you have to cull the herd," Hume said.

The burgers and snack wraps were still listed on the menu section of McDonald's website on Thursday. McDonald's did not immediately respond to confirm the introduction of the new Quarter Pounders.

In a bid to attract more customers in their 20s and 30s who are looking for fresher options, McDonald's recently added chicken McWraps to its core menu. According to an internal company memo obtained by Ad Age, the chain referred to the wraps as a "Subway buster" that would keep customers from heading to the sandwich chain.

Additionally, the chain now offers a version of its Egg McMuffins made with egg whites and a whole grain muffin. Customers are able to substitute egg whites into any breakfast sandwich.

McDonald's isn't the only one trying to refresh its menu. Burger King, Taco Bell and Wendy's have also been rolling out new items aimed at improving the image of their food. But traditional fast-food chains are trying to evolve in a tough economic climate, when they're also catering price-conscious customers.

Hospitals see surge of superbug-fighting products

A patient who contracted a superbug while in the hospital, shows a bottle of one of his daily medications on Monday, April 8, 2013 as he recovers at home in New York. The patient caught a bad case of a diarrheal illness caused by Clostridium dificile, while he was a kidney patient at New York City's Lenox Hill Hospital in fall 2012. (AP Photo/Kathy Willens)

NEW YORK — They sweep. They swab. They sterilize. And still the germs persist.

In U.S. hospitals, an estimated 1 in 20 patients pick up infections they didn't have when they arrived, some caused by dangerous 'superbugs' that are hard to treat.

The rise of these superbugs, along with increased pressure from the government and insurers, is driving hospitals to try all sorts of new approaches to stop their spread:

Machines that resemble "Star Wars" robots and emit ultraviolet light or hydrogen peroxide vapors. Germ-resistant copper bed rails, call buttons and IV poles. Antimicrobial linens, curtains and wall paint.

While these products can help get a room clean, their true impact is still debatable. There is no widely-accepted evidence that these inventions have prevented infections or deaths.

Meanwhile, insurers are pushing hospitals to do a better job and the government's Medicare program has moved to stop paying bills for certain infections caught in the hospital.

"We're seeing a culture change" in hospitals, said Jennie Mayfield, who tracks infections at Barnes-Jewish Hospital in St. Louis.

Those hospital infections are tied to an estimated 100,000 deaths each year and add as much as $30 billion a year in medical costs, according to the Centers for Disease Control and Prevention. The agency last month sounded an alarm about a "nightmare bacteria" resistant to one class of antibiotics. That kind is still rare but it showed up last year in at least 200 hospitals.

Hospitals started paying attention to infection control in the late 1880s, when mounting evidence showed unsanitary conditions were hurting patients. Hospital hygiene has been a concern in cycles ever since, with the latest spike triggered by the emergence a decade ago of a nasty strain of intestinal bug called Clostridium difficile, or C-diff.

The diarrhea-causing C-diff is now linked to 14,000 U.S. deaths annually. That's been the catalyst for the growing focus on infection control, said Mayfield, who is also president-elect of the Association for Professionals in Infection Control and Epidemiology.

C-diff is easier to treat than some other hospital superbugs, like methicillin-resistant staph, or MRSA, but it's particularly difficult to clean away. Alcohol-based hand sanitizers don't work and C-diff can persist on hospital room surfaces for days. The CDC recommends hospital staff clean their hands rigorously with soap and water — or better yet, wear gloves. And rooms should be cleaned intensively with bleach, the CDC says.

Michael Claes developed a bad case of C-diff while he was a kidney patient last fall at New York City's Lenox Hill Hospital. He and his doctor believe he caught it at the hospital. Claes praised his overall care, but felt the hospital's room cleaning and infection control was less than perfect.

"I would use the word 'perfunctory,'" he said.

Lenox Hill spokeswoman Ann Silverman disputed that characterization, noting hospital workers are making efforts that patients often can't see, like using hand cleansers dispensers in hallways. She ticked off a list of measure used to prevent the spread of germs, ranging from educating patients' family members to isolation and other protective steps with each C-diff patient.

The hospital's C-diff infection rate is lower than the state average, she said.

Westchester Medical Center, a 643-bed hospital in the suburbs of New York City has also been hit by cases of C-diff and the other superbugs.

Complicating matters is the fact that larger proportions of hospital patients today are sicker and more susceptible to the ravages of infections, said Dr. Marisa Montecalvo, a contagious diseases specialist at Westchester.

There's a growing recognition that it's not only surgical knives and operating rooms that need a thorough cleaning but also spots like bed rails and even television remote controls, she said. Now there's more attention to making sure "that all the nooks and crannies are clean, and that it's done in perfect a manner as can be done," Montecalvo said.

Enter companies like Xenex Healthcare Services, a Texas company that makes a portable, $125,000 machine that's rolled into rooms to zap C-diff and other bacteria and viruses dead with ultraviolet light. Xenex has sold or leased devices to more than 100 U.S. hospitals, including Westchester Medical Center.

The market niche is expected to grow from $30 million to $80 million in the next three years, according to Frost & Sullivan, a market research firm.

Mark Stibich, Xenex's chief scientific officer, said client hospitals sometimes call them robots and report improved satisfaction scores from patients who seem impressed that the medical center is trotting out that kind of technology.

At Westchester, they still clean rooms, but the staff appreciates the high-tech backup, said housekeeping manager Carolyn Bevans.

"We all like it," she said of the Xenex.