FDA approves Plan B One-Step for girls 15 and older without prescription

By JoNel Aleccia, Senior Writer, NBC News

4/30/13

U.S. regulators on Tuesday lowered the age limit for Plan B One-Step emergency contraception, approving it for sale to girls as young as 15 and agreeing it will be available without a prescription and on store shelves instead of behind pharmacy counters, Food and Drug Administration officials announced.

The move, which grants an amended application by drugmaker Teva Women’s Health Inc., is a separate action from a federal judge’s ruling earlier this month that ordered the FDA to make the so-called “morning after pill” available to girls and women of all reproductive ages. It comes just days before U.S. District Court Judge Edward Korman’s decision is set to take effect.

“The FDA’s approval of Teva’s current application for Plan B One-Step is independent of that litigation and this decision is not intended to address the judge’s ruling,” agency officials said in a statement.

Under the FDA’s latest action, the emergency contraception will now be labeled as not for sale tothose younger than 15 and will require proof of age. It will not be available where age cannot be verified, but will be sold during normal retail hours outside pharmacy hours, likely in the women’s health or family planning aisles. In addition, Teva has arranged to have a security tag placed on all cartons to prevent theft.

The action alters the FDA’s controversial decision in December 2011 not to make Plan B One-Step available over the counter to girls younger than 17. At that time, Health and Human Services Secretary Kathleen Sebelius overruled an FDA committee recommendation — and Commissioner Margaret Hamburg — to force the agency to limit access to emergency contraception to younger girls. That move was hotly disputed by medical experts who said the drug was safe and effective for girls and women and widely regarded as an effort to avoid political fallout for President Barack Obama’s administration during an election year.

In granting Teva’s amended application Tuesday, Hamburg said it was based on science that shows access to emergency contraception has the potential to decrease the rate of unintended pregnancies in the U.S.

“The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease,” Hamburg said in a statement.

U.S. Department of Justice officials are still considering whether to appeal Korman’s April 5 decision, which reversed the 2011 FDA ruling and orders the agency to make emergency contraception products that contain levonorgestrel available without age or so-called “point of sale” restrictions. The FDA has 30 days, or until May 5 or 6 to take action.

In a sharply worded 59-page ruling, Korman said the FDA’s decisions about the drug were “politically motivated, scientifically unjustified and contrary to agency precedent.”

The ruling appeared to apply to Plan B One-Step and generic brands of the morning-after pill, although Korman gave the FDA the option of limiting the expanded access just to Plan B One-Step, if the agency believed that the one-pill option was better than products that use two pills.

The Teva approval drew praise from officials at Planned Parenthood officials, who supported wider access to emergency contraception.

“While there are still practical questions to resolve, this is an important step forward to expand access to emergency contraception and for preventing unintended pregnancy,” agency President Cecile Richards said in a statement. “Emergency contraception is a safe and effective form of birth control that can prevent pregnancy if taken within five days of unprotected sex. This decision will eliminate some of the biggest barriers and hurdles that women face in getting emergency contraception when they need it, which means many more women will be able to prevent unintended pregnancy.”

However, the move to approve Teva’s application without addressing the judge’s order was sharply criticized by the reproductive rights advocates who brought the lawsuit in 2001.

“Lowering the age restriction to 15 for over-the-counter access to Plan B One-Step 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 or after the pharmacy gates have been closed for the night or weekend,” said Nancy Northup, president and chief executive of the Center for Reproductive Rights, which brought the lawsuit.

“These are daunting and sometimes insurmountable hoops women are forced to jump through in time-sensitive circumstances, and we will continue our battle in court to remove these arbitrary restrictions on emergency contraception for all women,” she added.

The application from Teva, based in North Wales, Pa., was pending before the judge’s ruling, FDA officials said. Denise Bradley, a Teva spokeswoman, called the approval “a significant milestone for women.”

Anti-abortion advocates objected to making emergency contraception more available to young girls  because they believe that the emergency contraception drugs induce abortions.

Plan B One-Step is an emergency contraceptive aimed at reducing the possibility of pregnancy if taken within three days of unprotected intercourse. It uses a single pill that contains a high dose of the same hormone used in birth control pills to prevent or delay ovulation, prevent fertilization or, in some cases, prevent implantation of a fertilized egg in the uterine lining. Plan B One-Step will not end a pregnancy if a woman is already pregnant and there is no medical evidence it harms a developing fetus, FDA officials said.

Plan B, available from generic manufacturers, uses two doses of levonorgestrel. Another emergency contraceptive, ella, or ulipristal, is a prescription-only product that prevents pregnancy when taken within five days of unprotected intercourse. The FDA’s decision Tuesday does not affect Plan B or ella.

Emergency contraception products do not protect against sexually transmitted diseases.

Related stories: 

• Judge: Make Plan B available to all girls without prescription

NBC News. FDA approves Plan B One-Step for girls 15 and older without prescription.  Retrieved from http://vitals.nbcnews.com/_news/2013/04/30/17989156-fda-approves-plan-b-one-step-for-girls-15-and-older-without-prescription?lite.

Diabetes warning over soft drinks

4/25/13

Drinking one or more cans of sugary soft drinks a day is linked to an increased risk of diabetes in later life, a study suggests.

A can a day raises the relative risk of diabetes by about a fifth, compared with one can a month or under, say European scientists.The report in the journal Diabetologia mirrors previous US findings.

A diabetes charity recommends limiting sugary foods and drinks as they are calorific and can cause weight gain.

The latest research was carried out in the UK, Germany, Denmark, Italy, Spain, Sweden, France and the Netherlands.Some 350,000 individuals were questioned about their diet, as part of a large European study looking at links between diet and cancer.

“The consumption of sugar sweetened soft drinks increases your risk of diabetes – so for every can of soft drinks that you drink per day, the risk is higher,” lead researcher Dora Romaguera from Imperial College London told BBC News.

She called for clearer public health information on the effects of sugary soft drinks.

“Given the increase in sweet beverage consumption in Europe, clear messages on its deleterious effect on health should be given to the population,” Dr Romaguera and colleagues conclude in their research paper.

‘Not definitive evidence’

An increased risk of diabetes was also linked to drinking artificially sweetened soft drinks, but this disappeared when body mass index was taken into account.

Fruit juice consumption was not associated with diabetes incidence, however.

Commenting on the results, Dr Matthew Hobbs, head of research at Diabetes UK, said the link between sugar-sweetened soft drinks and Type-2 diabetes persisted even when body mass index was taken into account.

This suggests the increased risk is not solely due to extra calories, he said. “Even so, it is not definitive evidence that sugar-sweetened soft drinks increase the risk of Type 2 diabetes, other than through their effect on body weight,” he added.

“We do, though, already recommend limiting consumption of sugary foods and drinks as these are usually high in calories and so can lead to weight gain if you have too many of them.

“This is important for Type 2 diabetes because we know that maintaining a healthy weight is the single most important thing you can do to prevent it.

“Statistics expert Professor Patrick Wolfe, from University College London, said the absolute risk of Type-2 diabetes is low at about 4% of the adult UK population.

“In and of themselves, sugary soft drinks are only part of the picture – they’re just one of the potential risk factors for Type-2 diabetes,” he said.

“But since they are one we can easily eliminate – by switching to diet soft drinks or, even better, cutting them out of our diets altogether – it makes good sense to do so.”

Reference

News Health. (2013). Diabetes warning over soft drinks.Retrieved from http://www.bbc.co.uk/news/health-22280297.

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Where do we go from here to eradicate this virus and protect children worldwide from this deadly virus?

Reference
Callaway, E. (2013).  Public health: Polio’s moving target. Nature. Retrieved from http://www.nature.com/news/public-health-polio-s-moving-target-1.12817.

Don’t panic over new bird flu outbreak, CDC cautions

A deadly outbreak of a new kind of bird flu has now sickened 16 people in China and killed six, but U.S. health officials on Friday cautioned that there’s no cause for widespread alarm.

The new influenza A H7N9 virus has not been seen before in humans, but it doesn’t appear to be transmitted easily among people, and there have been no cases detected in the United States, said Dr. Tom Frieden, the director of the Centers for Disease Control and Prevention.

“There are no specific steps people in this country can take. People can go about their daily lives,” he said.

Still, he said CDC officials are in close contact with Chinese authorities as they track the spread of the novel virus, which has been found in people from four Chinese provinces.

“At this point, there are several things that give us confidence that this is not spreading widely from person to person,” Frieden said.

For example, Chinese authorities have tracked 100 close contacts of people who got sick, and none of them became ill. With typical influenza, perhaps 20 percent to 30 percent of family members could be expected to develop the flu, Frieden said.

CDC is working with vaccine manufacturers to develop a seed strain to produce a vaccine to protect against the H7N9 virus, but that would only occur if there appeared to be widespread transmission. If that were necessary, it would not disrupt production of the seasonal vaccine, CDC officials said.

The agency issued a health alert for U.S. clinicians urging them to be alert for recent travelers from China who could show signs of the novel flu. CDC is also developing a diagnostic test that could quickly detect the virus.

No travel advisories have been issued, but CDC officials are reminding U.S. tourists in China to stay away from live poultry markets. That’s the same advice the agency has issued for about a decade, since outbreaks of SARS and H5N1 flu. The World Health Organization said it was not advising screening at points of entry or any trade restrictions in connection with the outbreak.

China’s neighboring countries are closely monitoring people for signs of flu. A 7-year-old girl in Hong Kong was being tested Friday in a local hospital for signs of the virus, according to the official Chinese news outlet Xinhua. Tougher surveillance also has started in Laos, Cambodia, Thailand and Taiwan, CDC officials said.

Though no source of the outbreak has been identified, Chinese officials have detected the virus in chickens and in pigeons and are now culling flocks to prevent further spread of the virus.

Health officials can’t yet say whether this virus is especially virulent. Wider population tests will need to be conducted to tell whether many people may have become infected with virus without becoming seriously ill, or whether those who got infected developed severe illness.

The virus appears to be common in animals, where it causes only mild illness. Doctors closely monitor cases of animal flu that pass into humans. Seasonal flu kills tens of thousands of people globally every year. But a new virus that starts passing from animals to people could cause far more serious disease.

For instance, H5N1 bird flu kills about 60 percent of the people it infects. But it doesn’t pass easily among people, either, and most of those who’ve gotten appeared to be directly infected by sick chickens.

Still, Frieden noted that flu can mutate very quickly and there’s no way to tell whether this new virus will soon become more transmissible. The H1N1 swine flu in 2009 didn’t cause serious illness, but it spread very quickly. And that bug was a descendant of the 1918 “Spanish flu,” which killed between 50 million and 100 million people worldwide.:

Related stories: 

• Six more diagnosed with new bird flu in China
• New bird flu strain: Little evidence of global threat so far

Source: http://vitals.nbcnews.com/_news/2013/04/05/17618253-dont-panic-over-new-bird-flu-outbreak-cdc-cautions?lite.

US state biosimilar substitution bill becomes law

  29/03/2013

Supreme Court Hears ‘Pay To Delay’ Pharmaceutical Case

The U.S. Supreme Court hears arguments Monday in a case worth billions of dollars to pharmaceutical companies and American consumers. The issue is whether brand-name drug manufacturers may pay generic drug manufacturers to keep generics off the market. These payments — a form of settlement in patent litigation — began to blossom about a decade ago when the courts, for the first time, appeared to bless them.

Consumer advocates, health care organizations and retail outlets call these payments “pay to delay.” The drugmakers hate that term and have a different name. They call the payments “reverse settlements.”

But the bottom line is that in these cases, the people who usually sue each other — the patent-holding drugmakers and the alleged patent violators (the generic drugmakers) — are on the same side, supporting the payments.

Challenging the payments is the Federal Trade Commission, which sees these monetary arrangements as collusion, a way to stop competition in the marketplace and a violation of the nation’s antitrust laws.

The drugmakers, in contrast, see the settlements as a routine way of settling a legal dispute, with each side getting something it wants.

The Patent Dispute

The case before the Supreme Court is fairly typical. It involves a patent on AndroGel, a prescription testosterone gel — a new version of an old drug. In short, the brand-name drugmaker Solvay had a new patent with a slightly different formula.

Generic competitors challenged Solvay’s patent, contending that the patent on the synthesized testosterone used in AndroGel had expired decades ago and that whatever innovative changes were made in the formula were not enough to justify a new patent that would bar generics from making similar products.

The litigation pressed on for two years with both sides gathering evidence. But as the lawsuit progressed into its third year, one generic won FDA approval for its competitive product, and was preparing to market it at prices that were six times cheaper than the brand named AndroGel. That would have put AndroGel’s $400 million annual sales into the tank

At that point, Solvay and the generics reached a settlement under which the generics would not market their competitive drugs for another nine years. And in exchange, Solvay would pay the generics a total of up to $42 million annually.

Defenders of settlements like this contend that each side is getting something it wants. The generic gets the payment, plus the certainty of going to market prior to the patent expiration but not as soon as it initially wanted.

Settling ‘Somewhere In The Middle’

As lawyer Kannon Shanmugam puts it, “Settlement is one of the rights that is virtually enshrined in our Constitution. And when you have one party who says that the patent is invalid and another party that says that the patent has another 15 years of patent life, it seems reasonable that the parties should have a variety of tools to settle somewhere in the middle.”

Opponents of such settlements, including retailers, hospitals and health insurance groups, contend that these “pay to delay” settlements should be presumptively illegal.

“These deals are unheard of in any other area of the law for a really simple reason,” says lawyer Tom Goldstein. “Nobody believes that if you’re the only company in the market and a competitor comes along, you can say to them, ‘I’ll pay you 10, 20, 50, or 100 million dollars to just stay out of the market. That’s the opposite of competition.” These payments extend monopolies, and “it hurts customers who would benefit from lower drug prices.”

The Federal Trade Commission is leading the charge against the payments in Monday’s Supreme Court case. It appealed to the high court after a federal appeals court upheld the Solvay payments. The agency is telling the justices that once a generic enters the market and competes with the brand-name drug, prices drop 85 percent.

The payments are not settlements but “old-fashioned, naked” agreements not to compete, said U.S. Solicitor General Donald Verrilli at Georgetown Law School earlier this month.

The FTC says that when generics actually take their patent challenges to trial, they win 73 percent of the time, but that generics settle because they often make more money by settling with the brand-name drugmakers than they would otherwise.

In response, lawyers for the drugmakers note that a patent is — in essence — a license given by the federal government to have a monopoly for a limited period of time. And they argue that if Congress wants to bar these reverse settlement payments, it can do just that through legislation.

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