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:, 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


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


GxP Perspectives LinkedIn Group


Please comment with your views and opinions!

A Better FDA? Why Not?

December 11, 2011


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.


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


Read the NY Times article on effective government

FDA Inspections: Will FDA’s New Food Safety Authority Leave Drugs & Devices Behind?

December 5, 2010

FDA authority food safety drug device inspection

FDA Food Safety:
How will it Impact Drug and Medical Device Inspections?

With the passage of the FDA Food Safety Modernization Act by the U.S. Senate, there has been concern that FDA will “choke on food” and not have adequate resources to conduct inspections of medical devices, human drugs, and biological products including vaccines. Although the bill still needs to reconciled between the House and Senate versions, funding is clearly going to be an issue as the new Congress is in a belt-tightening mood. Will FDA’s new food safety authority cut back on oversight of clinical trials and other drug and device inspections? This has been a discussion on the GxP Perspectives LinkedIn Group. My viewpoint is that the new food safety authority will not have an impact on Bioresearch Monitoring inspections (GCP & GLP) but probably will for routine GMP inspections of both pharma and device companies.

Why? The Bioresearch Monitoring (BIMO) program coordinates FDA inspections of Clinical Investigators, IRBs, Sponsors and/or CROs, Nonclinical Laboratories, and Bioequivalence/Bioanalytical research. The BIMO (pronounced bye-moe) inspections are coordinated, and payed for, by four FDA Centers; the Center Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER), and the Center for Veterinary Medicine (CVM) located at FDA’s headquarters in Silver Springs, MD. Remember, they have user fees from the Prescription Drug User Fee Act and the device user fee program. So if you are considering an application for approval, expect an FDA inspection.

Those of us in the drug and device development field often think that FDA’s primary authority is the approval of new health therapies. If you are an FDA employee at one of the Centers in Silver Springs, that just might be the case. However, the primary area the new FDA Food Safety and Modernization Act will impact is in the organization and management of the Office of Regulatory Affairs (ORA- the field organization) and the Center for Food Safety and Applied Nutrition.

FDA food authority drugs devices inspections

Bioresearch Monitoring is 5.4% of ORA's Workplan

Bioresearch Monitoring makes up around 5.4% of ORA’s workplan so it has never been their major focus. FDA has fallen behind in the biennial GMP inspection schedule for years, so I would anticipate that to continue, if not worsen. However, the mandated, and funded, inspections of clinical trials should continue unabated. Here are the numbers from the ORA Fiscal Year 2009 Workplan. (The new tobacco program is not included.) They show that food is the largest program. It always has been. ORA is funded by the Centers by the number of FTEs (full time equivalent employees) allocated by the centers to conduct inspections and laboratory analyses.

Food: 1,062 FTEs – 53% of Total
Human Drugs: 339 FTEs- (62.1 BIMO FTEs)
Medical Devices: 238 FTEs- (36 BIMO FTEs)
Vet Medicine: 118 FTEs- (4.4 BIMO FTEs)
Biologics: 115 FTEs- (4.4 BIMO FTEs)

TOTAL: 1,987 FTEs- (106.9 BIMO FTEs) – 5.4% of Total FTEs

These numbers tell an interesting story. ORA has 20 District Offices around the country. They also now have international offices for China, India, Europe, and Latin America. However, the primary focus is food, GMP, and import operations, not BIMO. Think about the amount of expertise and specialization the drug and device development industries require. There are times when one of the Centers will send specialists to work with an FDA BIMO Investigator. That is taking place more and more for sponsor inspections. Still, look at the numbers and do the math.

FDA food safety authority drug device inspections

FDA Needs Adequate Funding for Food, Drug & Device Inspections

I support passage of the FDA Food Safety Modernization Act. It will help FDA take Salmonella off of grocery store shelves and as a consumer I appreciate that. However, it is possible that drug and device GMP inspections might suffer. FDA BIMO inspections will continue at the same rate, but I am one to support a BIMO Modernization Act to help FDA update regulations and reorganize the inspection force. Most of all, FDA needs the funding to carry out the Food Safety Act as well as its other responsibilities, including GMP inspection of drug and device manufacturers and clinical trials.

ORA Workplans FY-2001 thru FY-2009

Update: Read Steven Grossman in FDA Matters on two strategies for FDA legislation in 2011.


Two Important New GCP Documents: There is a new Final Rule on required elements of Informed Consent. You can read the Federal Register Announcement here that includes FDA comments in the preamble. The exact change in 21 CFR Part 50 is:

“Sec. 50.25 Elements of informed consent.

* * * * *
(c) When seeking informed consent for applicable clinical trials,
as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be
provided to each clinical trial subject in informed consent documents
and processes. This will notify the clinical trial subject that
clinical trial information has been or will be submitted for inclusion
in the clinical trial registry databank under paragraph (j) of section
402 of the Public Health Service Act. The statement is: “A description
of this clinical trial will be available on
http:[sol][sol], as required by U.S. Law. This
Web site will not include information that can identify you. At most,
the Web site will include a summary of the results. You can search this
Web site at any time.”

There is a Draft Guidance on Electronic Source Documentation in Clinical Investigations. The comment period is for 90 day (April 4, 2011 ?)

Please join GxP Perspectives on LinkedIn at:

GxP Perspectives LinkedIn Group

Visit the TMF Page at the Top Right of the Blog! I am trying to assemble resources for those of us concerned with the Trial Master File. I welcome any contributions you might have of interesting articles and resource documents.


In news from GxP Perspectives. I will be participating in the conference, Developing CAPAs in the GCP Environment on January 18-19, 2011 in Arlington, VA.

FDA: Can This Agency Be Dangerous?

October 30, 2010

FDA Dangerous Agency

Academics Duel Over FDA & Drug Regulation

How dangerous is FDA? One of the most articulate critics of the pharmaceutical industry and FDA’s oversight of drug regulation has been Dr. Marcia Angell, the past editor of the New England Journal of Medicine and currently a Senior Lecturer in Social Medicine at Harvard University. She is also the author of the “must read” book, The Truth About the Drug Companies. She maintains that the agency has not lived up to its mission of approving safe and effective drugs. She has taken the occasion of the publication of the book Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA, by Daniel Carpenter (Princeton Studies in American Politics: Historical, International, and Comparative Perspectives), to write a scathing review in the September 30 edition of the New York Review of Books. Carpenter, a Professor of Government, is also at Harvard. Dr. Angell does not like this book and makes it very clear. And her negative review sparked a not-so-pleasant exchange between them in the October 28, 2010 edition where Angell accuses Carpenter of writing a “waspish letter” responding to her review. When Harvard academics flourish charges of being “waspish,” you know its serious.

Update: I am putting in a link for a memo by Dr. Carpenter responding to Dr. Angell’s review below.

I had been warned against tackling Dr. Carpenter’s 800 + page, rather dense history of FDA. I am leaving that to the good professor Sid Olufs, who periodically writes book reviews for GxP Perspectives (see the page at the top). However, Dr. Angell’s critique is harsh indeed. She faults Dr. Carpenter for the failure to bring out shortcomings with offices within FDA’s Center for Drug Evaluation and Research (CDER) and nine reforms that she considers important points about drug regulation in the United States and just how dangerous an agency FDA is. They are:

1. The Prescription Drug User Fee Act (PDUFA) should be repealed. I happen to agree, although I don’t think it was Dr. Carpenter’s intention to offer a polemic against the pharmaceutical industry. My experience in conducting PDUFA inspections for the agency for 10 years is that they are ineffective. We need public health inspections based on public health needs, not pharmaceutical dollars.

2. The Office of Surveillance and Epidemiology (OSE) should have more authority and independence from the Office of New Drugs. This involves Agency politics that is over my head. You can read Angell’s argument on the link below.

FDA agency dangerous

Conflicts of Interest on Advisory Committees

3. Members of CDER’s standing advisory committees should have no financial ties to drug companies (except for research support provided under carefully restricted conditions). I think that many of us are worried about the extent of drug company influence and the amount of money spent on that influence.

4. FDA should see that the post-marketing studies it requires as a condition of approval are carried out in a reasonable time period. This is a long overdue reform.

5. Approval of new drugs should be limited to three years, and during that time advertising aimed directly at the consumer should be prohibited. I’m not sure about the three years but I oppose direct-to consumer advertising.

6. FDA should review generic drugs as rapidly as brand name drugs and be adequately staffed to do so. A common sense reform.

7. In pre-marketing trials me-too drugs should be compared with an existing drug to treat the same condition, not just with a placebo. The debate over placebo controls in clinical trials is worthy of an entire book, maybe two. The Blog isn’t taking a position. Yet.

8. Dr. Angell’s eighth reform involves surrogate endpoints.
You will need to read her arguments on the link below.

9. As a condition for enrolling human subjects, all clinical trials, without exception, should be registered at inception in a public database at inception in a public database and the results shown when the research is completed. This might be easier said then done but greater transparency is a must in the future of clinical research.

FDA Agency dangerous

FDA Has a Long Ways To Go

GxP Perspective: This is a summary of Dr. Angell’s critique of FDA. I am not so sure. FDA is a very large agency and change will take time. I believe that change has been taking place incrementally and that FDA is doing a good job under difficult circumstances. While I agree with many of the points Dr. Angell raises, and highly recommend her book on the pharmaceutical industry, I think we need to look at the bigger picture. FDA is a much better agency than the one I left in January 2005. Let’s give some credit where credit is due. We’re lucky they are on the job.

The NY Review of Books Article by Dr. Angell on FDA: This Agency Can Be Dangerous

How Dangerous is FDA? An Exchange Between Daniel Carpenter and Marcia Angell

Dr. Carpenter’s Response Memo


In news from GxP Perspectives. I will be participating in the conference, Developing CAPAs in the GCP Environment on January 18-19, 2011 in Arlington, VA. (and again in January 2012)

Please join GxP Perspectives on LinkedIn at:

GxP Perspectives LinkedIn Group


Visit the TMF Page at the Top Right of the Blog! I am trying to assemble resources for those of us concerned with the Trial Master File. I welcome any contributions you might have of interesting articles and resource documents. Let me know!

In the Blogosphere: The nice folks at imarc have noted Mikki O’Neal’s Guest Commentary on IRB Training. Please check out their site: imarc

FDA To Honor Dr. Frances Kelsey

September 2, 2010

FDA honors Dr. Kelsey

President Kennedy Honors Dr. Frances Kelsey for Her Role in Drug Safety

The U.S. FDA is set to honor Dr. Frances Kelsey, a former medical reviewer who helped start the modern era of clinical trials 50 years ago. Dr. Kelsey prevented the approval of thalidomide in the United States because of concerns about peripheral neuropathy and the lack of testing on the drug’s safety. Among the drug’s proposed usages included treating morning sickness during pregnancy. It was unknown at the time that the drug would pass the placental barrier between a pregnant woman and the fetus. In Europe there were thousands of “thalidomide babies” born with terrible birth defects, including phocomelia, that left the children with deformed limbs sometimes resembling a seal type flipper instead of an arm or leg. The tragedy led to the Kefauver-Harris Amendments to the Food Drug and Cosmetic Act and the requirement for “adequate and well controlled trials” along with testing for safety.

FDA Commissioner Dr. Margaret Hamburg announced that FDA would honor Dr. Kelsey’s achievements.

50 years ago a relatively junior medical reviewer, Dr. Frances O. Kelsey said no to an application to market the drug thalidomide. Despite what she called un-relenting pressure from the manufacturer, she remained unconvinced of the drug’s safety especially its potential effects on the unborn.

Dr. Kelsey’s decision has been described as a game changer for the Agency and the country. Her action spared untold numbers of children in the United States from devastating birth defects caused by the drug and spurred the passage of legislation that gave the FDA authorities it needed to better protect the public health; setting it on a course to become the nation’s premier public health agency that it is today.

On Wednesday September 15th at 10:30 AM I will present a new Commissioner’s award, The Dr. France O. Kelsey Award for Excellence and Courage in Protecting the Public Health, to its first recipient, Dr. Kelsey herself. This award will be given on a regular basis by the FDA Commissioner to selected FDA employees.”

Congratulations to Dr. Kelsey. She certainly deserves the honor.

UPDATE: NY Times article on the event

Read Dr. Kelsey’s Bio from Chemistry Explained. It tells how she and her husband were among the first scientists to verify that some drugs that are safe for adults are dangerous to human embryos. Very interesting reading.

Save The Date: On 4-5 November 2010 the Pacific Regional Chapter of the Society for Quality Assurance (PRCSQA) and the Organization of Regulatory and Clinical Associates (ORCA), a Pacific Northwest based organization, will co-sponsor a Fall Training on regulatory compliance topics in Seattle, WA.

The PRCSQA LinkedIn Group will update the agenda for the training. PRCSQA Fall Training workshops have traditionally been “at cost” and are an affordable training opportunity. The sessions will cover both GCPs and GLPs with speakers lined up on vendor management, quality systems, and GLP updates.

++++In news from GxP Perspectives++++

Read the updated article on the Form FDA 1572 in:

Applied Clinical Trials “Closing Thought” on FDA 1572

ALSO: Please join me on LinkedIn at:

GxP Perspectives LinkedIn Group


FDA Wants Drug Withdrawn for Failure to Conduct Phase IV Studies- UPDATE: FDA Bows to Patients’ Concerns

August 16, 2010

FDA Phase IV Withdraw Approval

FDA Wants Phase IV Studies to Prove Effectiveness

(Original Post- UPDATE Below) The Food and Drug Administration proposed to withdraw approval of a drug treatment for low blood pressure. The drug is marketed as ProAmatine by Shire Development Inc. and as a generic by others called midodrine hydrochloride. FDA stated that “required post-approval studies that verify the clinical benefit of the drug have not been done.” This proposal takes place shortly after the Avandia advisory committee meeting sharply questioned the Phase IV study conducted by GlaxoSmithKline (GSK) called the Record study. It indicates that FDA is taking postmarketing studies much more seriously, both for safety and effectiveness. In a 2009 report by the Government Accountability Office (GAO) FDA was sharply criticized because of the number of postmarketing, or Phase IV, studies that had not been completed by the sponsors or had not been reviewed by FDA. THE GAO report said that FDA had never withdrawn a drug due to the failure to produce postmarket information. Now it looks like FDA will for the first time.

The FDA press release stated:

We’ve worked continuously with the drug companies to obtain additional data showing the drug’s clinical benefits to patients,” said Norman Stockbridge, M.D., director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research. “Since the companies have not been able to provide evidence to confirm the drug’s benefit, the FDA is pursuing a withdrawal of the product.”

Midodrine hydrochloride was originally approved in 1996 with a fast track approval for drugs that treat serious or life-threatening conditions. The condition, orthostatic hypotension, can cause people to feel dizzy or feint when standing up due to the inability to maintain blood pressure in an upright position. FDA issued a Proposal to Withdraw Marketing Approval and Notice of Opportunity for a Hearing to the companies that manufacture midodrine hydrochloride citing the failure to provide Phase IV clinical studies since that approval. After 14 years, FDA wants documentation that the drug works for the labeled indication. FDA;s current leadership is showing that they can read a GAO report, something that many of their predecessors didn’t. The companies marketing midodrine hydrochloride have the opportunity to request a hearing to contest FDA’s proposed market withdrawal.

UPDATE: 4 September 2010: The New York Times in a report by Gardiner Harris, reports that FDA returns midodrine to the market due to patient concerns. There are no alternative therapies to midodrine.

Read the NY Times Article

GxP Perspectives: From the viewpoint of this blog, it is the responsibility of sponsors to supply FDA with required postmarket data to support their applications. I certainly want patients to have access to necessary therapies. However, I do not want FDA approving drugs using anecdotal evidence. This defeats the concept of “adequate and well-controlled trials.” Drug companies should follow through on their commitments to run Phase IV trials and submit reliable data to FDA.

UPDATE: 28 August 2010- Patient Perspective: Please read the comments for a different viewpoint, that of the mother of a patient with orthostatic hypotension (the 3rd comment). You can read about this in the blog: Suzanne’s World

Read the Press Release

Link for Products Receiving Accelerated Approvals

In news from GxP Perspectives: Read the updated article on the Form FDA 1572 in

Applied Clinical Trials

ALSO: Please join me on LinkedIn at:

GxP Perspectives LinkedIn Group

Special Notice: The Blog was published in the Journal of Diabetes Science & Technology on the topic of Supervisory Responsibilities of Investigators with my colleagues Ann Berenbaum and Patti Young.

Access the Abstract Here


FOIA: Accessing Government Information

July 24, 2010

FOIA government information

How Is Government Information Made Available?

The Freedom of Information Act (FOIA) was passed to make government more transparent and information more accessible to the public. It is easier said than done. I worked as a backup FOIA Technician briefly at the FDA San Francisco District and you can’t imagine the number of requests that come in and the amount of work for an FOI Tech to redact proprietary information. It is a big job without a lot of resources committed to it. FDA anticipates request for certain documents and places them into their electronic reading room. You can access Warning Letters directly from FDA’s Home Page (scroll down on the right under “Recalls and Alerts”). The problem is they don’t anticipate many documents and, as the Government’s Attic people let us know, if it isn’t requested it isn’t necessarily produced. FDA has tried to improve that situation with the Transparency Task Force. Unfortunately it has had some mixed results. Here are two sites from FDA to look at. There is also the entertaining and informative FOIA presentation by Government’s Attic. It is information that we should all take a look at. FDA just might be one of the more accessible organizations although it still isn’t easy to access much of FDA’s information. Knowing where to look is certainly not easy.

Finally, the Washington Post has just completed a series on government secrecy, called Top Secret America,on security issues that doesn’t paint a pretty picture. Accessing government information is not becoming easier despite the FOIA.


FDA Transparency Task Force

Government’s Attic

Update: POGO on SEC

New on the Blogroll: I’m not the only GxP type with a blog. Here is a well-written blog by Jackie Mardell-
Two Decades and Counting

ALSO: Please join me at:

GxP Perspectives LinkedIn Group


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