Commentary on Plan B Controversy

December 28, 2011

Plan B Kathleen Sebelius

Kathleen Sebelius Overturns FDA on Plan B

Plan B is an emergency contraceptive, sometimes called “the morning after pill,” that has been approved as safe and effective for its intended use by the Food and Drug Administration. The drug’s safety is pretty much beyond dispute. However, it is access to Plan B that is proving controversial. In question is whether Plan B can be available over-the-counter or on a prescription basis for all women of child-bearing potential. This includes those under 18 years of age. FDA had said yes. In an unprecedented decision, the Secretary of Health and Human Services, Kathleen Sebelius, overturned a decision by FDA. The decision, in early December, has largely been overlooked by the general public with the onset of the holidays and college football bowl games. However, it has profound implications for millions of Americans and perhaps the way FDA approves drugs in the future. FDA Commissioner Margaret Hamburg issued a public statement after the decision defending FDA’s scientists who had recommended the OTC approval (see below).

The following Guest Commentary by April Mayberry discusses this decision. In it she gives her opinion on the Plan B decision. GxP Perspectives, as always, welcomes your own viewpoints and opinions.

When Politics & Science Collide

Plan B

Plan B Emergency Contraception

As a clinical research professional working in women’s reproductive health and contraceptive development, I was disturbed by Dr. Sebelius’ decision to override the FDA’s decision to allow OTC access to Plan B for girls under 17. First my reaction was concern about the impact this will have on women and contraceptive development. Second was to wonder why Dr. Sebelius, an Obama appointee with a strong reputation for supporting reproductive rights, would make such a decision.

In her statement posted on the HHS website, Sebelius said that Teva didn’t provide sufficient evidence that Plan B could be used safely in very young adolescent girls, or that they could understand the labeling. She said if Teva could produce data to the contrary they could refile. If Sebelius’ decision was intended to protect girls, it doesn’t seem logical.

• An adolescent girl has a much higher chance of serious complications from an unintended pregnancy or an abortion than from Plan B.

• Other potentially dangerous OTCs used, and even abused, by young women have no such restrictions. This includes diet pills, cold medicines, aspirin, ibuprofen and acetaminophen, all of which are associated with serious and/or fatal AEs.

• In my experience, controversial products not indicated to treat immediately life-threatening conditions must meet a particularly high approval standard. In a public statement appearing on the FDA website, FDA Commissioner Margaret Hamburg said:

“The Center for Drug Evaluation and Research (CDER) completed its review of the Plan B One-Step application and laid out its scientific determination. CDER carefully considered whether younger females were able to understand how to use Plan B One-Step. Based on the information submitted to the agency, CDER determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.” In the same statement Dr. Hamburg contended that:

Dr. Margaret Hamburg, FDA Commissioner

Dr. Margaret Hamburg, FDA Commissioner

“The review process used by CDER to analyze the data applied a risk/benefit assessment consistent with its standard drug review process. Our decision-making reflects a body of scientific findings, input from external scientific advisory committees, and data contained in the application that included studies designed specifically to address the regulatory standards for nonprescription drugs. CDER experts, including obstetrician/gynecologists and pediatricians, reviewed the totality of the data and agreed that it met the regulatory standard for a nonprescription drug and that Plan B One-Step should be approved for all females of child-bearing potential.”

So if FDA used the standard review process why isn’t it enough? Most agree this decision was not based on science. One can only speculate why Sebelius, an Obama appointee, with a strong record regarding women’s reproductive rights, would do this. Possible reasons that come to mind are:

There has been pressure from the religious right on the government against Plan B and contraceptives in general. Plan B is of particular contention, because some mistakenly believe that it terminates pregnancy. Reportedly while governor of Kansas, Sebelius at times modified policy under pressure when it was seen as a political advantage
(also reportedly in these instances the decisions didn’t pose a risk of clinical or other harm to women. In light of reports that she is a subject of backlash by the church.) and of a lawsuit by Belmont Abbey College over the mandate requiring them to provide contraceptive coverage in their health plan, it’s feasible OTC access to Plan B for girls under 18 was sacrificed in lieu of mandates Sebelius considers more crucial, such as requiring health-care plans to provide contraceptive coverage. (Sources: RealityCheck.org, National Catholic Register, and Washington Times)

Plan B access

Should Teenagers Have Access to Plan B?

Regardless of the actual motives behind this move, it has a real potential for negative ramifications. Requiring a young girl to consult an HCP (most having limited office hours) poses potentially insurmountable obstacles to accessing Plan B in the time it’s most effective, possibly resulting in an unintended pregnancy. She must have access to an HCP, know how to navigate the system, have transportation and maybe money. For a young woman who is in a dysfunctional situation or is victim of sexual abuse, these barriers could compound their duress and risk, especially if a pregnancy resulted.

Women over 17 are also affected. Having to present an ID to a pharmacist can cause distress for some. Additionally many pharmacies have limited hours, and in some states some pharmacists may refuse to provide Plan B under the “conscious clause”, all causing delays in accessing it within the optimal treatment window. This is of particular concern for poor women in some rural or inner city communities with few pharmacies and for women with no ID.

Sebelius’ decision may also stifle contraceptive development. According the New York Times this is the first time that the HHS has blocked approval of a product by the FDA. This sets a precedent, allowing approval of contraceptives or other controversial medical products to be blocked without scientifically valid reasons. This is very problematic, because it allows those with political motives to take our national policies and the scientific process hostage to fulfill their own agenda, simply by applying enough political pressure.

April Mayberry, RAC, CCRA, CCRP, CFPHW *

* Certified Family Planning Health Worker

Dr. Hamburg’s Statement on Plan B

Secretary Sebelius’ Statement on Plan B

Pharmacist “Conscious Clause”

NT Times article on Sebelius curtailing availability of Plan B

National Catholic Register Article on Sebelius

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January GCP Training Opportunities:

ExL Pharma has announced that FDA’s Dr. Leslie Ball will give the Keynote Address at the 2nd annual Developing CAPAs in the GCP Environment conference held 19-20 January in Arlington, VA.

GxP Perspectives is a media sponsor.

At the same time and the same place the Trial Master File Summit is taking place with some excellent speakers. Find out more:
TMF Summit Information

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GxP Perspectives LinkedIn Group

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Please comment with your views and opinions!


Happy Holidays to One and All

December 23, 2011

Happy Holidays

Happy Holidays

It’s the time of the year to think of families, fun, and maybe those less fortunate than ourselves. Whatever holiday you celebrate, I hope that it is super. We have a Guest Commentary coming Monday on the controversial decision regarding Plan B by DHHS Secretary Sebelius. Then we will have end of year wrap ups on Warning Letters for Active Pharmaceutical Ingredients, Clinical Investigators, and Sponsors. GxP Perspectives has a new Editorial Intern, Francesca Carreras-Velez. We’ll see what she has to say! As always, I am looking for Guest Commentaries. For more info, please leave me a message.

Happy Holidays One and All!

Carl Anderson, GxP Perspectives


A Better FDA? Why Not?

December 11, 2011

FDA

A Better FDA?

Is FDA necessary? Most people I know would say yes. We need a strong, independent, effective FDA. Does FDA need improvements? Again, most people I know can point to numerous issues that FDA could handle better. Today, in the Business Section of the New York Times, there is an article on why we need government and the benefits of better government. Yes, the article by Robert H. Frank is about the Tompkins County New York Department of Moter Vehicles, but he outlines some basic principles for better government. Like better use of technology to make government more efficient. FDA is making similar efforts regarding technology. That’s great and I encourage the development. Here are three other areas that I think that FDA can improve:

1. Consistent training for field investigators (CSOs or Consumer Safety Officers). Many times people tell me of an FDA inspection in Salt Lake City that is entirely different from another inspection I have heard of in Tampa, FL. Different CSOs have completely different approaches and conduct the same type of inspection by looking at completely different documents. There are many excellent, experienced CSOs but when different clinical sites or sponsors hear differing viewpoints from CSOs, that isn’t good for compliance or best practices.

2. Changing requirements by review divisions. FDA will tell a sponsor to conduct a study with certain endpoints in order to prove safety and efficacy for their investigational product. Then, as the sponsor is preparing for their application, the rules change. This can cost a sponsor years of frustration and millions of dollars. Yes, safety concerns need to be addressed, but sponsors need to know the rules in advance, and have a reasonable expectation of those rules staying in place.

3. Effective mechanisms for corrective actions. FDA has a Warning Letter close out process. However, it is not evenly applied by different Centers and for different program areas. Regulated industry should have a clear path to performing corrective actions that are meaningful.

So those are my thoughts. I would love to hear yours. Please leave a comment.

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One additional point: My wife, Cathy J. Tashiro, just had her book come out in paperback. No, it has nothing to do with GxPs or clinical trials, she is a sociologist. Her book is:

Standing on Both Feet: Stories of Older Mixed Race Americans

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Read the NY Times article on effective government


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