FDA Moves Forward With OTC Plan B-One Step Approval

Since April 2013, we’ve been closely following the legislation ordering emergency contraception (like Plan B One-Step and its generics) to be accessible over the counter, without any age or point-of-sale restrictions. Check out the latest developments below, and continue checking back for more coverage.  

Emergency contraception is now closer to making its debut on store shelves. Yesterday,the FDA approved the use of Plan B-One Step without a prescription for women of all ages. This announcement marks the FDA’s compliance with the April 5 order by Federal Judge Edward Korman, which ordered the FDA to make levonorgestral-based emergency contraceptives available without any age or point-of-sale restrictions.

While Korman originally asked that all morning after pills of this type be available on store shelves, his back-and-forth battle with the DOJ ended in a compromise on June 10, when they announced that they would make Plan B One-Step (the most popular brand on the market) available without restrictions and Korman accepted this. As a result of that, Plan B’s manufacturer provided a supplemental new drug application to the FDA, and the FDA approved this on Thursday.  The only downside: this still means that the cheaper generic and two-pill versions of emergency contraception will remain behind the pharmacy counter.

This approval by the FDA does mention that Plan B One-Step is a drug that is safe and effective for women of all ages. It also reinforces the point that emergency contraception will not stop a pregnancy if the woman is already pregnant and that there is currently no medical evidence to suggest that it would harm a developing fetus.

While there is no word yet on when we can expect to see Plan B next to the condoms, it seems encouraging that the FDA was speedy in their approval of the new guidelines. Check back soon for updates.

photo: alpimages/Shutterstock

More from Women’s Health:
Plan B One-Step in the Works to Hit Store Shelves
Obama Administration Reverses Course on Plan B 
What Is Emergency Contraception? 

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UPDATE: Plan B One-Step In the Works to Hit Store Shelves

Since April 2013, we’ve been closely following the legislation ordering emergency contraception (like Plan B One-Step and its generics) to be accessible over the counter, without any age or point-of-sale restrictions. Check out the latest developments below, and continue checking back for more coverage

In long overdue news, unrestricted access to Plan B One-Step is actually in the works. Yesterday, Federal Judge Edward Korman approved the FDA’s proposed plan from earlier this week to make Plan B One-Step available without any age or point-of-sale restrictions.

Judge Korman originally ordered all levonorgestral-based emergency contraceptives to be moved OTC for women of all ages back in April. After much back and forth, the Department of Justice announced on Monday that they would comply with his order to make Plan B One-Step (the leading brand of emergency contraception) available without restrictions. Now that Judge Korman has accepted this plan of action, Plan B’s manufacturer (Teva) will submit an application to the FDA, which will likely lead to new labeling and packaging for the drug. Once the FDA approves this, they’ll work to get the drug on store shelves as soon as possible.

But Judge Korman made it clear that there is still work to be done here. In his letter yesterday, he notes that allowing one brand to have exclusivity may still deter some women from getting the drug, since it would mean that lower-cost generics remain behind the pharmacy counter.

“I think his commentary does not have any limiting power over the fact that it is now in the FDA’s and Teva’s hands to work this out,” says Susannah Baruch, interim president and CEO of the Reproductive Health Technologies Project.

So when can we expect to see it next to the condoms? Unfortunately, the FDA application and approval process will take time, and experts can’t venture a guess as to how long we’ll have to wait. Check back soon for any updates.

photo: Mert Toker/Shutterstock 

More from Women’s Health:
Obama Administration Reverses Course on Emergency Contraception
Should Birth Control Be Over The Counter? 
What is Emergency Contraception? 

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Breaking: The FDA Approves OTC Plan B

It’s official: In response to a court-ordered mandate, the FDA has given drugstores the green light to start selling emergency contraception over the counter to women 15 and older. The upshot? You’ll now be able to get Plan B even if a pharmacy’s not open when you need it—like, say, at 2 AM, right when the accident happens.

For more information on what these changes mean, read Women’s Health’s original report on the judicial ruling to take emergency contraceptive out from being the pharmacy counter.

photo: iStockphoto/Thinkstock

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Read This If You Plan to Buy a Home—Ever!

Even if you’re nowhere near ready to lock down a piece of property, you may want to start planning for the future. Housing prices in December 2012 rose 6.8 percent from the same period in 2011, which is the biggest jump we’ve seen since 2005, according to the latest report from the S&P/Case-Shiller Home Price Indices (the leading measures for the U.S. residential housing market).

“Even though prices have gone up slightly, right now really is the perfect time to buy,” says Danisha Danielle Hoston, financial expert and principal of Hoston & Associates real estate. “Prices are still lower than they have been and interest rates are still lower than they have been in most of our lifetimes.” While that doesn’t mean you should rush out with your down payment in hand if you’re not ready, it’s certainly a wake-up call for anyone who is considering buying a house in the near future. Here, how to get prepared—no matter what stage you’re in:

If you’re at least 5 years away from buying your first home….

Check Your Credit
“Guard your credit fiercely,” says Hoston. That means no late payments, no forgotten bills, and always staying below 25% of your credit limit. In addition to checking your regular credit score, find out your FICO score, too. “FICO scores are the type of scores that most mortgage lenders use,” says Liz Weston, financial expert and author of Deal With Your Debt. Finding out your score early on means you’ll have plenty of time to do some damage control if it isn’t where it should be.

Make a Better Budget
Setting a spending plan for yourself before you actually need it can help you see where all your money is going (and if you maybe need to cut down on your weekend shopping sprees). Weston suggests the 50-30-20 plan (coined by newly-elected Senator of Massachusetts Elizabeth Warren): Take your gross income after taxes and chop that in half, which should account for all your necessities like housing, transportation, utilities, and insurance. Then take 30 percent for the fun stuff (like happy hours, new clothes, and vacations) and the remaining 20 percent goes toward savings and debt repayment. “If you can get that in order before you even start your quest for a house, you’ll already have a balanced budget to help you start saving,” says Weston. For more tips on how to establish a budget, check out The Best Apps for Saving Money.

If you want to buy something in the next year…

Be Strict About Your Spending
Even with a rock-solid budget, you’ll probably need to carve out a little extra savings for things like the down payment, mortgage payments, and closing fees. “Really consider avoiding large purchases right now, because this going to be the most important large purchase you’re going to be making,” says Hoston.
Meanwhile, don’t close a credit card account at this time—even if you never use it. “[Mortgage lenders] like to see a big gap between the credit you have available and the credit you are using,” says Weston. Similarly, try not to open any new accounts just yet either, since it may bring down your score slightly.

Know the Fees Ahead of Time
When saving up for this enormous purchase, it’s crucial to know all the costs you’ll encounter along the way. For instance, your down payment may be anywhere from 3.5 percent to 20 percent of your total cost, says Weston. And while it’s typically good to put down as much as possible, you may also want to put down less if it means jumping on a property you love at a time when the interest rates are low, Hoston says. And don’t forget about the closing costs (they averaged $ 3,700 on a $ 200,000 mortgage last year, according to Bankrate) and broker fees (sellers may end up paying 3% to both their agents and the buyers’ agent, according to Weston). The bottom line: Get educated about the potential costs you’ll encounter, and save up accordingly.

Start Shopping Around
When you’re between six months to a year out, you’ll want to get pre-approved through a lender to find out what you can afford, says Hoston. But like all big purchases, it pays to be a comparison shopper. “Get a few different options. Credit unions typically have lower fees than conventional banks,” says Hoston. Once you’ve been pre-approved at one bank, you can take that information to another one to see if they can beat it—either in terms of price or when it comes to your payment schedule.
Then hit the streets—or at least your computer—to start figuring out which neighborhoods match your price range. Sites like Zillow.com and StreetEasy.com are great for getting an idea of average costs, but a savvy real estate agent will clue you in to how close the asking prices are to the actual selling price, says Weston.

If you want a house—now!

Make Smart Money Decisions
Even though home prices are starting to increase, it’s still a great time to be a buyer. “Think about taking advantage of the lowest interest rates and fixing them for a period of at least 10 years, because inevitably they will go back up,” says Hoston. You’ll give yourself some peace of mind knowing that your rates won’t be crazy-big in the future.
And if you need more help with your mortgage payment, you might want to consider buying a multiple unit home that you can rent out. You’ll end up with an investment property and the income from your tenants may cover some—or even all—of your mortgage payments, says Hoston.

Keep Saving
After you sign on the dotted line, make sure you’ll still have enough money left over to actually enjoy your house—not to mention decorating, maintenance, and your mortgage payments. “One rule of thumb is to make sure you save at least 1 percent of the value of the house every year just to go towards maintenance and repairs,” says Weston. And even though you probably won’t use it every year, it’s crucial to have it saved for emergencies.

Splurge On Inspections
It may seem like just another added cost that you don’t feel like paying, but consider the inspection as a necessary part of the buying process. “Some money that I do recommend spending is on the complete inspection report. Don’t hire your cousin Willy to do a walk through on the property,” says Hoston. “This is very good money well spent.” And that includes things like termite and mold reports, which can all lead to even bigger costs down the line.

Don’t Rush It
Just because the time is right for buyers, that doesn’t mean you should grab the first set of house keys you find. “One thing I worry about is people panicking themselves when they’re not ready to make a decision,” says Weston. “My advice is to buy a house when you’re ready, you can afford it, and you’re going to stay put for a while.” Not only do you want to love your new home enough to stay for a few years, but it also takes 3-5 years for the appreciation of a house to offset the costs of moving again. That said, if you find your dream home while the costs are still low, go for it!

photo: iStockPhoto/Thinkstock

More from Women’s Health:
Money Rules That’ll Make You Rich
Money Help 411
The Money Mistake You’re Probably Making

 

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Do You Have an Emergency Action Plan?

Quick test: Where is the closest emergency exit? If you’re not sure, you’re not alone. A new UCLA study shows that people often do not recall things they’ve seen or walked by hundreds of times, including important things like emergency exits and fire extinguishers.

To gather data, study researchers asked 54 people who work in the same building if they knew the location of the fire extinguisher nearest their office. While many had worked in their offices for years and had passed the bright red extinguishers several times a day, only 13 out of the 54—24 percent—knew the location, according to the study.

“Sometimes we stop paying attention to things that we think we know, only to find out we don’t actually know them that well,” says Alan Castel, PhD, an associate professor of psychology at UCLA and lead author of the study.

In emergency situations, this can be incredibly dangerous and possibly life threatening. Be prepared for any and all situations by creating an Emergency Action Plan (EAP). Use the following guidelines from Ready.gov, launched by the Department of Homeland Security (DHS) and the Federal Emergency Management Agency (FEMA), to help you get started.

Customize your plan
While it’d be easiest to download a cookie cutter EAP from the Internet, it’s not the best option. According to Ready.gov, you need to take into account individual needs and responsibilities based on methods of communication, types of shelter, and available transportation.

When creating your EAP, keep in mind:
• Different ages of members
• Responsibilities for assisting others
• Locations frequented
• Dietary needs
• Medical needs including prescriptions and equipment
• Disabilities or access and functional needs including devices and equipment
• Languages
• Cultural and religious considerations
• Pets or service animals

Don’t rely on your memory
Once you have all of the necessary information in order, fill out an EAP card on Ready.gov’s website and keep it in your wallet. This way, you won’t have to remember meeting places, phone numbers, and other important life-saving information. Get the EAP cards, here.

Prepare your home
You can also further prepare yourself and your family by assembling an at-home emergency kit (anyone who experienced Hurricane Sandy recently know how handy these can be). Get Ready.gov’s at-home checklist, here.

photo: iStockPhoto/Thinkstock

More from WH:
36 Emergency Survival Tips
How to Unmask Your Inner Hero
Tips for Dealing with a Medical Emergency


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