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Regulatory Affairs News and topics related to marketing laws, regulations and guidelines. Includes news feeds from FDA, including press releases, advisory committee meeting announcements, and drug safety notices.

View Poll Results: Who do you think was right — Sebelius or Hamburg?
Sebelius 7 26.92%
Hamburg 19 73.08%
I can't say for sure 0 0%
Voters: 26. This poll is closed

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  #1  
Old 8th December 2011, 05:57 AM
Pharma Newshound Pharma Newshound is offline
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Default Sebelius vs. Hamburg on OTC Plan B Decision

This is an unprecedented conflict between HHS and FDA. See



[Was Sebelius Right to Block Broader Plan B Availability? Respond to the poll.]

"A Statement by U.S. Department of Health and Human Services Secretary Kathleen Sebelius"

Source: Press Release

[see Sebelius's letter to Hamburg attached; see Hamburg's statement below]

Plan B One-Step is an emergency contraceptive, sometimes referred to as the “morning after pill.” Plan B One-Step is currently labeled over the counter to women ages 17 years and older, but is sold behind the pharmacy counter. It is available by prescription only to women 16 years and younger. My decision does not change any current availability of the drug for all women.

In February 2011, Teva Women’s Health Inc. submitted to the FDA a supplemental new drug application for Plan B One-Step. This application sought to make Plan B One-Step available over the counter for all girls of reproductive age. The science has confirmed the drug to be safe and effective with appropriate use. However, the switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately. I do not believe that Teva’s application met that standard. The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use.

FDA has recommended approval of this application in its Summary Review for Regulatory Action on Plan B One-Step. After careful consideration of the FDA Summary Review, I have concluded that the data, submitted by Teva, do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age.

The average age of the onset of menstruation for girls in the United States is 12.4 years. However, about ten percent of girls are physically capable of bearing children by 11.1 years of age. It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age. If the application were approved, the product would be available, without prescription, for all girls of reproductive age.

The Secretary of the Department of Health and Human Services is responsible, acting through the FDA Commissioner, for executing the Federal Food, Drug, and Cosmetic Act. Today’s action reflects my conclusion that the data provided as part of the actual use study and the label comprehension study are not sufficient to support making Plan B One-Step available to all girls 16 and younger, without talking to a health care professional. Plan B One-Step will still be available over the counter to women ages 17 and older.

Because I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age, I have directed FDA to issue a complete response letter denying the supplemental new drug application (SNDA) by Teva Women’s Health, Inc..

----------------

"Statement from FDA Commissioner Margaret Hamburg, M.D. on Plan B One-Step"

Source: FDA Press Release

Date: December 7, 2011

The U.S. Food and Drug Administration (FDA) has been carefully evaluating for over a decade whether emergency contraceptives containing levonorgestrel, such as Plan B One-Step, are safe and effective for nonprescription use to reduce the chance of pregnancy after unprotected sexual intercourse.

Plan B One-Step is a single-dose pill (1.5 mg levonorgestrel tablet) which is effective in decreasing the chance of pregnancy if taken within 3 days after unprotected sexual intercourse. The product contains higher levels of a hormone found in some types of daily use oral hormonal contraceptive pills and works in a similar way to birth control pills.

Plan B One-Step was originally approved in July 2009 for use without a prescription for females age 17 and older and as a prescription-only option for females younger than age 17. In February 2011, Teva Women’s Health Inc. submitted a supplemental application seeking to remove the prescription-only status for females younger than age 17 and to make Plan B One-Step nonprescription for all females of child-bearing potential.

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.

It is our responsibility at FDA to approve drugs that are safe and effective for their intended use based on the scientific evidence. 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.

I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER, and I agree with the Center that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.

However, this morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential. Because of her disagreement with FDA’s determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved. Following Secretary Sebelius’s direction, FDA sent the complete response letter to Teva today. Plan B One-Step will remain on the market and will remain available for all ages, but a prescription will continue to be required for females under the age of 17.
Attached Files
File Type: pdf Sebelius_PlanB_Letter_120711.pdf (64.6 KB, 131 views)
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Last edited by Pharma Newshound : 8th December 2011 at 07:23 AM.
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  #2  
Old 14th December 2011, 11:11 AM
Pharma Newshound Pharma Newshound is offline
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Default Free the FDA!

Source: NY Times OpEd

THE unilateral decision last week by Kathleen Sebelius, the secretary of health and human services, to block the Plan B One-Step contraceptive pill from being sold to adolescents without a prescription is shocking in more ways than one.

Not only was it unexpected, but for the first time in American history, a cabinet secretary — and by extension, a president — has overruled a drug-approval decision by the Food and Drug Administration.

The precedent risks placing the real power for drug approval not just with a cabinet secretary, but with the White House itself. The only solution, then, is to make the F.D.A. truly independent. Americans have already done this, through the Federal Reserve, to protect our money supply from political meddling; it’s time to do it for drugs.

True, Ms. Sebelius’s decision was entirely legal: the federal Food, Drug and Cosmetic Act of 1938 gives authority to “the secretary” in the department in which the F.D.A. resides. And F.D.A. rulemaking — the creation of new regulations that govern not a specific case but a range of activities, like rules for testing or the way drug companies synthesize their compounds — has long been overseen by high officials, not least by the president’s Office of Management and Budget and, before that, by the secretary of health and human services and her predecessors in previous departments with different names.

But the decision nevertheless sets a radical precedent. The key part of the Food, Drug and Cosmetic Act holds that no drug can be sold in interstate commerce without prior approval by the F.D.A. And until last Wednesday, the decision of the F.D.A. commissioner was final. That power still rests with the federal government, but as a result of last Wednesday’s decision, it now arguably rests in the White House.

That’s not just a symbolic change; it could have drastic effects on regulatory policy. The F.D.A. entrusts drug-review decisions to its scientists. In its first few decades, the F.D.A. collaborated with scientific societies to develop technical standards for evaluating drugs, standards that have now been emulated worldwide.

After the thalidomide tragedy of the early 1960s, in which a newly hired medical officer refused to approve the drug in spite of tremendous pressure (it was instead distributed through a clinical testing program), the F.D.A. and the Department of Health and Human Services began to codify these “subdelegation” patterns — that is, giving final say to the F.D.A. — into federal regulation. Federal courts have uniformly upheld these arrangements: they have the sanction of law as well as of scientific practice.

The possibilities opened by this decision are frightening. A radical pro-business secretary could now, in principle, bypass the clinical trial system and the F.D.A. approval process and decide to approve a drug. A different secretary, one distrustful of the pharmaceutical industry, could stop a drug despite strong scientific support behind it.

As a result, other countries might easily decide that American drug approval no longer carries scientific weight, hurting our companies’ exports and the international fight against infectious diseases.

The solution is to do something that many F.D.A. watchers have been proposing for at least a decade: Take the F.D.A. out of the Department of Health and Human Services and make it an independent agency, like the Fed.

Such an arrangement would give the commissioner a fixed term of six years, dischargeable only for cause. In the same way the president can’t overrule Fed decisions on interest rates, there would be no president or cabinet to overrule the F.D.A.’s decision to approve or deny a drug. (Of course, the Administrative Procedure Act would still apply, and these decisions would still be reviewable on procedural grounds, as they are now, in court.)

To be sure, an extreme micromanaging president might, in theory, be able to request the resignation of his F.D.A. commissioner to apply political pressure. But with an independent agency he would not be able to hide behind his cabinet secretaries, as President Obama did.

Critics of this idea will point out that the F.D.A. is equipped to review drugs from a health and safety point of view, not from a moral one. This is a reasonable point. But it doesn’t follow that the secretary or president should have a blanket veto over its decisions. Congress could easily establish a law providing for separate bioethical review.

At the very least, President Obama and Ms. Sebelius need to clarify what their precedent entails. If they don’t, we can expect to see lobbies from all corners of society — drug companies themselves, safety advocates, groups of doctors and patients — walk directly away from an F.D.A. decision they don’t like and take their cases to the White House.

We would never allow this sort of second-guessing when it comes to our financial health. We should have the same standards when it comes to our public health.

Daniel Carpenter is a professor of government at Harvard and the author of “Reputation and Power: Organizational Image and Pharmaceutical Regulation at the F.D.A.”
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  #3  
Old 9th January 2012, 09:40 AM
Pharma Newshound Pharma Newshound is offline
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Default Plan B advocates take their case to Obama’s science adviser

Source: Washington Post

‘Morning-after pill’ advocates take their case to Obama’s science adviser

By David Brown, Published: January 7

Advocates for unfettered access to the “morning-after pill” Plan B One-Step took their case to President Obama’s chief science adviser Friday, asking him to find out the basis for the administration’s controversial decision last month to continue requiring that young teens get the drug only by prescription.

In brief presentations wedged into a meeting of the President’s Council of Advisers on Science and Technology, five experts decried Health and Human Services Secretary Kathleen Sebelius’s rejection of the Food and Drug Administration’s move to make Plan B available over the counter.

“We are asking you to work with us . . . to readdress this decision, find out how it was made and why,” Wayne C. Shields told John P. Holdren, the chairman of the council. Shields is president of the Association of Reproductive Health Professionals, a trade organization with offices in Washington.

In her allotted two minutes of public comment, Francesca T. Grifo of the Union of Concerned Scientists quoted Sebelius’s Dec. 7 letter that rejected the FDA’s plan to make Plan B available to girls younger than 17 without a prescription.

“Secretary Sebelius used phrases like ‘based on my review’ and ‘my conclusion,’ ” Grifo said. “This is exactly the situation which scientific integrity policies are created to prevent: namely, a non-scientist, political appointee overturning a decades-long process of scientific research and review both inside and outside of the FDA.”

Afterward, however, she and the others said the issue didn’t involve “scientific integrity” as commonly understood.

“This not about fraud, not about misconduct.” Shields said. “It is about standing up to the stated principles.”

As Obama’s adviser for science and technology, Holdren has no direct influence over either Sebelius or FDA Commissioner Margaret Hamburg. It’s unclear how Sebelius’s decision to keep some restrictions on Plan B access could be undone short of Obama ordering her to undo it. That action would probably be more controversial than Sebelius’s overruling of Hamburg.

Holdren told the speakers: “I will communicate the concerns that were expressed here to my boss.” He also addressed the issue of scientific integrity.

“What scientific integrity requires is that the clearest and most objective evidence be made available” to decision-makers, he said. “That does not necessarily guarantee that the scientific findings alone will determine the outcome.”

“Emergency contraception” — a dose of the hormone progesterone taken up to 72 hours after intercourse — has been controversial since it was first tested more than a decade ago.

Some opponents say it will encourage sexual activity by girls or make exploitation of them easier. Some view it as hazardous, although studies have shown it works and has no serious side effects. Some view it as an abortion pill, as it can prevent the implantation of a fertilized egg in the uterus.

The first formulation of Plan B was approved by the FDA in 1999. In 2004, the agency rejected an application to make it available without a prescription. In 2006, however, such availability was allowed for women 18 and older. In 2009, the age restriction was changed to 17 and older.

The drug is not “over the counter” in the sense that it can be picked off the shelf like a bottle of aspirin. The purchaser must show proof of age, and the drug can be handed over only by a pharmacist.

In its most recent application to the FDA, Plan B’s maker, Teva Women’s Health, was seeking to lift all restrictions, making the product easier to buy. The FDA told the company it had to conduct further studies on whether girls younger than 17 could take the drug properly.

“No product ever has had to do age-breakdowns like that,” said Susan F. Wood, an associate professor at George Washington University’s School of Public Health who in 2005 resigned her job as an assistant FDA commissioner in protest of the long delays in changing Plan B’s status.

Teva submitted more data last February. They included the results of two kinds of studies: a “label comprehension” study assessing whether girls as young as 11 understand the directions on the Plan B box, and an “actual use” study recording the experience of girls as young as 11 who used the drug to prevent pregnancy. But according to an article in the Journal of the American Medical Association last month, there were no 11- or 12-year-olds in the “actual use” study because none showed up at the clinics where the study was run.

In her letter overruling the FDA decision, Sebelius noted that some girls start menstruating at age 11 but that Teva’s studies “do not include data on all ages for which the drug would be approved.” She implied — although did not say outright — that the lack of data on 11-year-olds was the basis for her decision.

Experts in emergency contraception, however, say that because pregnancy in 11-year-olds is so rare it would be virtually impossible to ever get “actual use” data for that age group.
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