By John Jalsevac
WASHINGTON, D.C., August 9, 2006 (LifeSiteNews.com) – After three years of wrangling between the Food and Drug Administration and Barr Pharmaceuticals Inc. it appears that the drug company is suddenly on the brink of finally getting what it wants—over-the-counter access to the abortifacient Plan B or “morning after” pill.
The most recent development in the three-year-long battle indicates that Plan B could very wellÂbe available over-the-counter within a matter of mere weeks.
Early last week it was reported that the FDA contacted Barr Laboratories Inc., the manufacturer of the “emergency contraceptive” Plan B, indicating that it wanted to meet within seven days to discuss new steps the company must take in order to sell the abortifacient without a prescription. Among the requirements that the FDA laid out was that Barr would table a plan to restrict over-the-counter access to those over the age of 18.
The most recent development is that Barr has agreed to revise its application accordingly and to resubmit within two weeks, agreeing to restrict the drug to those over 18.ÂIt is, however,Âstill unclear exactly how the company intends to go about enforcing the age restriction, which many, including the FDA,Âhave said in the past isÂanywhere fromÂdifficultÂto impossible.
The FDA promised that it would act quickly on the revised application, according to a Bloomberg news report.
The chairman of Barr, Mr. Downey, told the NY Times that the acting Food and Drug Commissioner, Andrew C. von Eschenbach, had promised to work with the company to resolve the current deadlock . Although initially the company had hoped to be able to obtain permission to provide unrestricted over-the-counter access to Plan B, with no age limit, Downey admitted “I don’t have the ability to get all that I want.” Previously the pharmaceutical company had partially compromised andÂpetitioned to make Plan B available over-the-counter to anyone over 16.
Although the FDA has said that the decision to renew negotiations over Plan B are fuelled by science rather than politics, the not even thinly veiled timing of the current push for over-the-counter access has left opponents more than a little sceptical about the FDA’s objective consideration of the factualÂmerits or demerits of such a plan.ÂLast week Concerned Women for America (CWA) responded to the renewed debate by criticizing the FDA, which it says “consistently puts women second to politics”.
In this case the FDA’s announcement to renew discussions with Barr came only one day before senate hearings into confirming the FDA’s acting commissioner Andrew von Eschenbach were set to begin. Senate Democrats including Senators Hillary Clinton and Patty Murray,Âhave clearly voiced their intent to block theÂnominatinon of Eschenbach for FDA commissioner until the Plan B issue is resolved in their favor—that is, until the FDA makes Plan B available over-the-counter.
Since the beginning of Eschenbach’s senate hearings a series of major developments in Barr’s application have occurred in rapid-fire succession, culminating in the most recent news that Plan B could be available over-the-counter within mere weeks.
CWA President Wendy Wright has condemned Barr Pharmaceutical’s push to for over-the-counter access to Plan B, saying, “Any scheme based on who buys the drug is absolutely meaningless. Anyone, man or woman, over 18 could buy the drug and turn around – even in the store – and give it to a 13-year old. Neither FDA nor Barr, the Plan B drug maker, has the ability to penalize those that would sell or give the drug to a minor. No one can believe that the FDA or Barr could enforce a gender restriction on sales so that only women can buy it but men could not.”
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In response to the arguments of advocates of Plan B that it reduces unwanted pregnancies and abortions, Wright responded, “Countries that make the morning-after pill easy to access show no drop in pregnancies or abortions, but they do experience skyrocketing rates of sexually transmitted diseases (STD). Common sense and care for women – especially minor girls – requires medical oversight of this drug. The FDA needs to stop playing games with women’s lives.”
See related LifeSiteNews.com coverage:
FDA Commissioner Hearings Begin: Nominee Takes Heat from Both Sides of Abortion/Plan B Debate
https://www.lifesitenews.com/ldn/2006/aug/06080301.html
FDA Reopens Debate on Over-the-Counter “Morning After Pill”
https://www.lifesitenews.com/ldn/2006/jul/06073107.html
Report on Abortion-Causing Morning-After Pill Shows FDA Used Great Caution
https://www.lifesitenews.com/ldn/2005/nov/05111505.html
US Bishops Tell FDA Over-The-Counter “Morning-After” Pill Would Be Harmful to Minors
https://www.lifesitenews.com/ldn/2005/oct/05102803.html