Ibuprofen and Claritin, both household names, used to only be available as prescription drugs. But while the government approved those medications without stipulations, limitations are being placed over more controversial medicines.

In January 2005, Barr Pharmaceuticals, Inc. announced that its emergency contraceptive pill, Plan B, was being looked at by the U.S. Food and Health Administration to be approved as an over-the-counter drug.

But after months of debate, the FDA sent Barr Pharmaceuticals a letter last month still denying the company the right to distribute the Plan B as an over-the-counter drug because the FDA could not reach a decision regarding regulatory issues with the pill.

‘It’s frustrating really. I mean, even Susan Wood resigned,’ said Betty DeFazio, a representative with Planned Parenthood of Syracuse. ‘That shows her own frustration.’

Wood, the assistant commissioner of the FDA resigned last week because of the government’s refusal to make a decision on the matter.

The FDA wants to put an age restriction on the over-the-counter Plan B pill, something that has never before been done for any other drug. The restrictions would grant patients ages 16 and above access to the pill, while those patients younger than 16 must obtain prescriptions from a health care provider.

In the FDA’s official statement on the matter, Commissioner Lester M. Crawford said there are still difficult questions that must be considered before making a decision on the matter including whether or not age should be a criterion whether or not a drug can be offered over the counter.

Crawford said that whether Plan B is sold as a prescription or over the counter and how the limitations on age will be enforced are important issues that the FDA must look further into.

‘What if 16 is not young enough?’ said Carly Furst, a freshman information technology major. ‘These days girls are more sexually active at such a young age.’

Despite the age controversy, Crawford said that the FDA still wants the issues associated with the Plan B pill to be ‘considered an open, public process.’

‘I think there are political concerns that lawmakers and policy makers wish to add the dimension of age,’ said Kathleen Van Vechten, director of nursing at SU Health Services. ‘The risk of pregnancy is greater then the risk of Plan B.’

The issue of age is a concern to the FDA mostly because of accessibility. The FDA does not want those younger than 16 abusing Plan B as a primary form of birth control, Crawford said.

Van Vechten said accessibility to Plan B is a bad thing. Increasing accessibility will decrease health care dollars because those seeking the pill will be able to buy it in drug stores instead of making appointments with a health care provider.

She said women using Plan B as a primary form of contraception is a real possibility, but it is a risk that is worth taking.

‘I had a friend who thought she might be pregnant, so I think in certain cases it’s all right,’ said Maria D’Angelo, a sophomore inclusive elementary and special education major. ‘But it shouldn’t be abused.’

Crawford said the Center for Drug Evaluation and Research concluded the data it collected showed that the use of Plan B as an over-the-counter product would only be appropriate for women ages 17 and older.

Plan B works as a progestin-only contraceptive pill. It works by using a higher dose of the ingredients found in ordinary prescription birth control pills. The higher dose ‘tricks’ the body into thinking it is pregnant, causing the system to be flushed and a new menstrual cycle to begin. Even though it can prevent pregnancy, Plan B is not and should not be used as an everyday method of birth control, Van Vechten said.

‘We care about women getting the health care that they need to get,’ DeFazio said. ‘Women need to take this in a timely way and anything that prevents that will be an obstacle.’

If it is taken anywhere up to 72 hours after unprotected sexual intercourse, the chance of preventing pregnancy becomes significantly greater.

Within 24 hours after unprotected sexual intercourse, there is an 89 percent chance of pregnancy being prevented, Van Vechten said.

Health centers such as SU’s Health Services and Planned Parenthood offer Plan B as an emergency contraceptive; however, this does not mean that they are easily accessible to anyone, both Van Vechten and DeFazio said separately.

Both organizations require all patients looking to obtain a Plan B prescription go through a thorough screening process to see if the drug is appropriate for them. Van Vechten said the consultation, conducted by a nurse-practitioner, consists of a health screening, an informed consent session and a follow-up after the prescription is taken.

The patients go through a thorough screening process to assure that they understand what it is they are asking for, said Van Vechten.

Plan B is an emergency contraceptive pill that is currently a prescription medication. ‘The Morning-After Pill,’ as it is more commonly referred to, will remain a prescription drug while the proceedings between the FDA and Barr Pharmaceuticals continue.

‘I think the important thing to know is that women are intelligent and they know how to take care of themselves,’ DeFazio said.

Published on September 5, 2005 at 12:00 pm