India: Quality for Clinical Trials

March 1, 2012

India clinical trials quality assurance

Quality Systems in India

Are Quality Systems in place in India, where the clinical trials industry is exploding?Do clinical trials professionals have the knowledge, skills and experience to run clinical trials where the rights, safety, & welfare of human subjects is protected and where data are reliable for submission to FDA and EMA> In this Guest Commentary QA professional Anusha Reddy demystifies the GCP process in India outlining her approach to quality in clinical trials.

This marks the first edition of GxP Perspectives as a monthly blog. It has been too much work for one person to keep up with a weekly schedule. I will be using the GxP Perspectives Linkedin Group to keep on top of current developments with FDA, as well as discussions by group members. Also, youcan subscribe to the blog on the button to your right on the sidebar.

Join the GxP Perspectives Linkedin Group Here

Improvising Quality in Clinical Trials

By Anusha Reddy

Over the last decade Clinical Trials in India have increased very rapidly in number. India has made a name for itself in the international pharmaceutical field as an ideal destination for worldwide companies to conduct clinical trials which is a test for both the government and the private sector to create a balance between ethics and trade The rise in the business brought sharp focus on the need to manage quality while conducting clinical trials.A need was, however, felt to develop our own Indian Guidelines to ensure uniform quality of clinical research throughout the country and to generate data for registration for new drugs before use in the Indian population. An Expert Committee set up by Central Drugs Standard Control Organisation (CDSCO) in consultation with clinical expert has formulated GCP guideline for generation of clinical data on drugs.

The Drug Controller General of India (DCGI) has introduced several guidelines and regulations, in an effort to maintain and ensure credibility, integrity, safety, well being and quality of clinical trials, some which includes guidelines on approval of clinical trials, CTD, Clinical trial Inspection, registration of clinical trials, CROs, and Ethics Committee’s. It constituted NDAC to review applications of new drugs and clinical trials, introduced prescreening of applications in order to expedite and streamline the process of application by ensuring completeness and has recently made compensation mandatory for injury or deaths during trials and which would increase the number of volunteers and patients going for a trial in India, according to experts.
.

quality clinical trials in India

"Each Stage of Data Handling"

Quality in clinical trials should be applied to “each stage of data handling” to ensure that all data are reliable and have been processed correctly. Clinical trials are carried out to allow safety and efficacy data to be collected to provide information for industry and regulators to make decisions about the safety and efficacy of the interventions. Activities like monitoring and auditing are performed in order to ensure that the quality exists and the study is conducted in accordance with the SOPs, Protocol, GCP and applicable regulatory requirements. Pharma and Biotech firms are looking for several different strategies in clinical trials to ensure the highest quality of data. This article tries to discuss on describing and executing the quality in clinical trials.

A good quality clinical trial should, address an important question, have the potential to make an actual difference to patients, use the finest available research techniques, generate significant data, be scientifically and ethically sound. Recognition of GCP at the sponsor, CRO and the investigator site will improve the quality of clinical trials and finally leads to the acceptance of clinical trials.

clinical trials quality India

"Ability to Satisfy Stated or Implied Needs."

As per ISO (International Organization for Standardization) quality is defined as the features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs. In clinical trials, poor quality has much more serious outcomes than discontented customers. Failure to ensure quality in clinical trials can result in undue harm to research participants, invalid data, and consequently, wrong conclusions about the safety and efficacy of the drug being tested. Additionally poor quality is a call for a regulatory inspection.

Determined efforts to improve quality in clinical trials have increased noticeably over the past decade. Recently the Department of Medical Education has imposed a temporary ban on clinical drug trials and research projects in all government and private medical colleges and hospitals in the Karnataka State, India; however, later it was assured that no such measures are being undertaken. The reason behind such decision was especially lack of guidelines to regulate drug trials. An expert committee was set up to study and frame guidelines to regulate and re-organise clinical drug trials, which is a step towards a quality clinical trials.

quality India clinical trials

The Consequences of Poor Quality

There are several reasons for poor quality in clinical trials and preventing them all is not an easy task. The objective should be to limit their number and their effect on the trial outcomes. This can be achieved by taking steps at the initial stage in protocol development and at the trial set up phase to obtain a high quality data in clinical trials; however, this alone does not result in high quality. Furthermore, planning should be accompanied by adequate oversight through proper routine monitoring and auditing of the trials with necessary corrective and preventive actions (CAPA) in place.

Measures should be taken to promote quality improvement in clinical trials by following standard operating procedures and implementing good documentation practices while performing study activities like drug accountability, Informed consent process, Safety reports, protocol deviations/violations and other protocol related activities which will provide reliable results and error free data when submitted to regulatory agencies for approvals.

A quality system proposition to good clinical practice conformance will establish quality in clinical trials by identification and setup of standards, applying them by those involved in the conduct of clinical trial, tracking the areas that are non-complaint with the standard procedures or applicable regulatory requirements, take actions to prevent the recurrence in future in the identified areas.

quality in India

Developing Metrics

Developing and using metrics that are meaningful within an organization facilitate in measuring the quality in clinical trials. For example, preparing a protocol from the stage of drafting to finalizing, here with increase in amendments the time increases and quality is reduced (but number of amendments is often not the reflection of protocol quality). Other example for measuring the quality includes the number of data clarifications forms (DCFs) raised per case report form (CRF); increase in the number of data queries indicates the poor data quality. Based on these metrics one can measure the quality and can improve those areas.

In Conclusion, systems with procedures or measures that assure the quality of every aspect of the clinical trial should be implemented. Quality should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly. This extent of transparency and accountability of clinical trial processes ensures ongoing quality control and quality assurance, but in addition, makes it easy to assertively address inquiries from regulatory agencies.

Useful Links:

Indian GCP

Clinical Trial Registration

Prescreening Checklist

====

Training Opportunity:

The 3rd Proactive GCP Compliance Conference taking place April 2-4 in Arlington, VA – GCP Conference Website. Leading GCP experts from Lilly, Pfizer, J&J, Novartis, Shire and many more address risk-based approaches to clinical quality that meet requirements and ensure patient safety. Special 15% discount off of the standard registration rate for GxP Perspectives readers. Register online at: GCP Conference and use discount code: P439GXP

====

DIA Regulatory Conference this April in India

====
In News From FDA:

FDA has issued the final guidance, “IRB Continuing Review after Clinical Investigation Approval.” GCP Guidance Documents may be found here: FDA GCP Website. The new guidance is on the right in the section “In The News.”

From: A Message from the Commissioner
Sent: Wednesday, February 29, 2012 04:14 PM
To: FDA-Wide
Subject: Announcement re Chief Counsel

Dear Colleagues,

I am thrilled to announce the permanent appointment of Elizabeth Dickinson as the Chief Counsel of the Food and Drug Administration, effective Monday, March 12, 2012.

As many of you know, Liz has had a long and distinguished history at the Agency; she joined the Office of the Chief Counsel in 1994. Over the years, Liz has served as legal counsel to the Center for Drug Evaluation and Research and the Office of the Commissioner on innovator and generic drug review issues, orphan drug development, and biosimilars; has implemented pediatric exclusivity and pediatric drug development programs; has worked closely with the Department of Justice on dozens of cases addressing Waxman-Hatch issues and preemption; and has coordinated the development of the Office of the Chief Counsel’s flexible workplace program.

A graduate of the University of Massachusetts and Northeastern University School of Law, Liz is highly regarded by both her internal colleagues and those across the food and drug bar. Over the years, Liz has received numerous awards for distinguished service, leadership and her outstanding legal skills.

Liz has been serving as Acting Chief Counsel since August 2011, and we have been grateful for her hard work and dedication each day that she has been on the job. It is terrific to know that she will be serving the Agency in this role permanently as we move forward. Please join me in congratulating Liz.

Sincerely,
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs

We have some excellent comments on this post. Please join the discussion and add your own thoughts


European Qualified Persons & New EU Anti-Falsification Legislation

February 7, 2012

qualified persons anti-falsification legislation

EU Anti-Falsification Legislation

In the European Union an EU certified “Qualified Person” or QP must certify that any batch of medicinal product is in compliance with applicable regulations before it can be released for sale or distribution. Although originally intended for Good Manufacturing Practice, the requirement for QP oversight is now in place for pharmacovigilance and drug products used in clinical trials. The QP is required to have extensive industry experience and the academic credentials, such as pharmacist or chemist, to provide robust, independent oversight of medicinal products.

The EU has enacted new legislation regarding anti-falsification. In this Guest Commentary, Wolfgang Schmitt, Administration Manager European QP Association, discusses the implications of the legislation for Qualified Persons. The falsification of data is a primary concern in the United States as well. Last year FDA introduced a proposed rule for reporting the falsification of data in clinical trials. On both sides of the Atlantic regulators are increasing their anti-falsification enforcement.

Guest Commentary

The Anti-falsification Legislation: Potential Consequences for QPs

The 6th QP Forum of the European Qualified Person Association (EQPA) was held in Budapest, Hungary on 1-2 December 2011 with two parallel pre-conference sessions on 30 November. One Focus was on the new EU anti-falsification legislation and its potential consequences for Qualified Persons.

EU Qualified Person anti-falsification legislation

Tamper Resistant Seals

A first presentation on this topic was given by David Cockburn, Head of Manufacturing and Quality Compliance, European Medicines Agency (EMA) in London, U.K.. David emphasised the need for the directive to “secure integrity and authenticity of products”. The new safety features like serial numbers and/or tamper-evident seals will mainly have an impact on the QPs at parallel distributors as they need to make sure that the authenticity and the integrity is confirmed prior to the removal of original safety features. And this removal of course has to be done under GMP.

Regarding the more stringent rules for the importation of APIs, the QP needs to besatisfied that the supplier qualification procedures ensure verification that suppliers are registered and that the supplier has been audited. This has to be documented in the QP Declaration. After qualifying the supplier it needs to be ensured that the raw materials are actually received from the qualified sources. When it comes to excipients, the QP should at least check that a formal risk assessment has been performed and documented and that the suppliers are qualified accordingly. This should also take into account information in the EU database for excipient suppliers. However an audit is not mandatory but should be preformed for any excipient identified as critical. Regarding the delegated acts, industry and the QPs need to wait for further details. However the QP will need to be satisfied that procedures are in place to comply with the defined conditions for import of APIs e.g.

EU anti-falsification legislation

An Industry Perspective

The aim of the second presentation was to elaborate the industry’s perspective. As Senior Manager Quality & Regulatory Affairs at the European Generic Medicines Association (EGA), Julie Maréchal-Jamil was presenting different aspects. Julie asked the question, how long the overall implementation really will take. Besides the Delegated Acts, other steps need to be taken. It will be interesting to see, how the EC List of Equivalent Countries[1] will be implemented. In the implementation phase of the new Directive, existing guidelines need to be revised and even new ones need to be developed like for example to define risk-assessment principles for excipients or to describe the various confirmations. Julie stressed that currently, there is “no legally defined timeframe for the development and publication of delegated and implementing acts” only a legal timeframe for the entry into force of these legislative acts once they are adopted by the EC.

EGA’s main concerns with the implementation of the Directive on Falsified Medicines are:

1. The so-called “Written Confirmation” of compliance with EU GMP for APIs from non-EU origin. For this process no guidelines are foreseen. Amongst others, EGA sees necessity in having a transition period and a possible risk of heterogeneous supervision of pharmaceutical import and waiver granting in different Member States in the absence of a coordination effort. Here a common central approach will be needed.

2. Process for the establishment of the list of EU GMP “Equivalent Countries.” Here, EGA recommends to leverage existing and operating initiatives like e.g. PIC/S, or MRA and ACAA agreements but also on other similar successful initiatives (Food and Feed) where a staged approach to implementation led to a smooth transition towards a level playing field.

3. Registration of API-related activities for EU-based API manufacturers, importers and distributors (article 52a). For EU multi-sites companies, duplication should be avoided.

4. Pharmaceutical Excipients GMP/GDP. Here, Guidelines should provide a fair reflection of today’s best practices, focusing on cost-effectiveness and existing standards like ISO. Unnecessary over-regulationshould be avoided.

5. Authority/inspectorate funding of the implementation. Details on EGA’s point of view will be published in a White Paper. Both the Forum and the pre-conference workshops were rated very positive by the almost 220 delegates. A survey amongst the delegates resulted in an overall rating of 1.56 (where 1 was the best rating and 6 the worst).

anti-falsification legislation for qualified persons

Budapest

Again very much appreciated was the social event on Thursday evening. Four busses with well selected guides took the QPs for an interesting sightseeing tour through Budapest, the famous capital of Hungary. Followed by a dinner in a traditional restaurant on top of Gellért Hill, the participants were able to continue their discussions and share their experiences with their colleagues in a relaxed atmosphere.

The 2012 QP Forum will be held in Hamburg, Germany on 22 – 23 December with preconference sessions on the 21 November. At the EQPA Advisory Board on 02 December 2011 in Budapest, a structure was defined and first presentations and parallel sessions identified.

Wolfgang Schmitt
Administration Manager
European QP Association, an Interest Group of the ECA Foundation
P.O. Box 10 21 68
69011 Heidelberg
Germany
EMAIL: info@qp-association.eu

U.S. Conference on European GMPs and the role of the QP

There will be a conference in Bethesda, MD on 27-28 June 2012. The conference goals are: “The European Compliance Academy ECA and the European QP Association, recognising this need for further professional knowledge development, intend to support the pharmaceutical industry outside Europe in understanding the European approach and legal framework in this respect. Therefore the QP Association has set up the programme at hand on European GMP requirements and the role of the QP.”

European Compliance Academy

====

Please join us: GxP Perspectives LinkedIn Group

GxP Perspectives on twitter: @GxPPerspectives


Drug Accountability in Clinical Trials

January 19, 2012

clinical trials study drugs

Drug Accountability in Clinical Trials

Drug Accountability Is the one thing that everyone looks at and everyone ignores in clinical trials. I don’t know how many times I have read in a monitor’s report that “drug accountability not done due to time restraints.” Yet consistently “test article accountability” (as FDA refers to it) is one of the top findings on a Form FDA 483, Inspectional Observations, issued for clinical trials. In this Guest Commentary pharmacist Roberta Wong outlines the basics for clinical trial professionals. She concludes with six issues for clinical trial sites to consider. She is a consultant to biopharmaceutical companies and teaches at the Pharmaceutical BioEngineering Program at the University of Washington.

Guest Commentary by Roberta Wong, PharmD

Drug Accountability in Clinical Trials

It’s not exciting, it’s not cutting edge. It may be the last thing you think about when preparing for an FDA audit. You might scan the records and figure if all the lines are filled in, it must be okay. Or, the auditor might not look at it, so I will trust that the pharmacist did it correctly. After all, aren’t pharmacists one of the most trusted professions? Consider this: if drug accountability is in question, then the whole study could be in jeopardy. Proving that the drug was administered to the patient that resulted in the effects seen from study drug is a key factor in determining the merit of a product candidate. The FDA has listed drug accountability as #3 in a list of top 5 pitfalls.

drug accountability in clinical trials

What FDA Considers

The FDA uses these categories for determining the seriousness of a deficiency. Sometimes, minor sloppiness is due to poor record keeping. This can be corrected with training, and close follow-up to insure consistency amongst staff. Sloppiness, if bad enough, can cause removal of data from study results, impacting the overall quality of the data, and the integrity of the study conduct. Often unintentional, lack of attention to detail, and not understanding the importance of accurate recordkeeping in the drug application can contribute to a clinical trial site’s data being thrown out of a sponsor’s application. Training staff at the study initiation visit and checking the quality of the work during the course of the study is critical for good record keeping to be maintained during the clinical trial. Staff can change, so retraining may be needed as new staff members are added to an ongoing study.

drug accountability in clinical trials

Intent to Deceive?

On the other hand, some inconsistencies in drug accountability can be due to a true intent to deceive. Drug supplies that are listed as destroyed, lost, or dropped, can be traced to individuals diverting supplies for themselves, or with the intent on selling study drug to other individuals. Investigational drugs can also be switched in an attempt to give drug preferentially to certain patients, if there is also a placebo as part of the study. Limiting access to investigational drugs is a key role for the pharmacist in studies conducted at large institutions. At smaller sites, or individual physician’s offices, study drug may be held by research or nursing staff. In these situations, limiting access and providing locked security for study drugs is required by the study sponsor.

So, what happens when a clinical trial site has drug accountability problems? If this occurs during a clinical trial, the Sponsor will stop new drug shipments, and may suspend study enrollment temporarily. Visits to the site by the sponsor will ascertain the cause of the problem, and determine if re-training will prevent future issues. During this investigation, reviewing the records with the study coordinator and the prinicipal investigator are imperative. And of course, documentation of any meetings with site staff summarizing the corrective action is essential. Ongoing audits for the remainder of the trial will demonstrate that the interventions were successful, and the site is now compliant in maintaining accurate drug accountability.

drug accountability in clinical trials

"Shooting the Dice" with Your Clinical Trial?

Drug accountability is more than just counting pills and vials. Site staff must insure that the study subject receives the study drug, and receives the correct dosage. There should be documentation to support drug administration. If the patient self-administers study drug, often diaries and pill vials are collected to validate the administration of study drug. If the drug is administered at a clinic visit, there are often forms to complete to verify the dosage that was given to a study subject.

How can you avoid problems with drug accountability? First, make sure that all involved in the study are consistent with their documentation. Make sure that the records are completed with the drug dose, patient, date, time and individual removing drug from the central inventory. If study drug is administered in the clinic, the worksheet should note the date, and actual time that the drug was given. If drug is not administered, even though a dose was prepared, then a note should record that drug was destroyed. If study drugs require refrigeration, then the accountability records should have a place to note the temperature.

Lastly, issues with accountability need to be addressed quickly and a solution determined. Vigilance in accurate documentation will insure minimal issues. Making sure the patient received the proper dose is one more way to insure that well-run clinical trials produce good quality data.

How do you know if your system is set up to produce good drug accountability? Here are some questions that you can answer about your study.

Questions to consider:

1. Did the patient receive the proper dose? How do you know?

2. Did the Physician calculate the correct dose? Who double checked the calculation? Is it weight-based? Is the dose calculated at study enrollment? Is the dose recalculated based on the patient’s baseline weight or dose the dose change only if the weight changes by 10%?

3. Drug was sent to the clinic to prepare a dose, and the patient was a no show. Should the drug be signed back into the central inventory? (If the drug should be refrigerated, and you are unsure of how the drug was stored, what should you do?)

4. Drug was prepared for a patient who was a no show, but promised to come in the next day. Can you save the prepared dose and administer it the next day?

5. Does your clinical trial allow documentation of these issues in the study records?

6. For study drug accountability, who resolves new issues? Where do you record your answer? How do you train the rest of the staff regarding this issue?

Contact Robbie!

====

Please join us: GxP Perspectives LinkedIn Group

GxP Perspectives on twitter: @GxPPerspectives


FDA Warning Letters for International APIs in 2011

January 8, 2012

API FDA Warning Letter International firms

API Warning Letters to International Manufacturers

FDA issued at least ten Warning Letters to international manufacturers of active pharmaceutical ingredients in FY-2011. Manufacturers in both China and India, the world’s largest exporters of APIs, received three Warning Letters each from FDA. Manufacturers in Spain, the UK, Canada, and Japan each received one Warning Letter from FDA. These metrics show both the domination of China and India in the API market as well as the continued dependence on international manufacturers for APIs destined for the U.S. market.

Deficiency Categories:

The violation that dominated the charges cited by FDA in FY-2011 related to quality control, cited in four Warning Letters, two to China and one each to Canada and Japan.

FDA API Warning Letters in 2011

Failure to Have Procedures for Cross Contamination

Another violation that is sure to cause concern with FDA is the failure to prevent cross-contamination. When I attended FDA API inspection training in 2000 cross-contamination, particularly with anti-biotics, was a major concern. It continues to be with API manufacturers in both India and China being cited for the “Failure to have appropriate procedures in place to prevent cross-contamination.”

Out of specification (OOS) laboratory results are always a concern of FDA and landed on Warning Letters to manufacturers in India and Spain. Other citations include:

= Water purification for APIs used in parenterals

= Failure to establish a stability program to monitor APIs

= Failure to perform at least one identity test of each batch of incoming material

= Validation of analytical methods used to test APIs

There are no big surprises here but it shows that regular surveillance of API vendors is an absolute necessity for the manufacture of quality drug products. What is of interest is that GxP Perspectives couldn’t find any domestic Warning Letters for APIs. That doesn’t mean they don’t exist, only that they couldn’t be easily located. Unfortunately, FDA lists API Warning Letters in any number of classifications for GMPs for finished pharmaceuticals. However, they don’t seem to list them for APIs. With all the razzle-dazzle taking place on FDA’s website, you would think they could come up with a consistent way to list API Warning Letters. Who knows, maybe next year.

by Carl Anderson, GxP Perspectives
Research by Francesca Carreras-Perez, GxP Perspectives

====

Two articles of interest regarding APIs:

Indian API Manufacturers want anti-dumping duties

API Product List (note countries of origin)

====

Please join us: GxP Perspectives LinkedIn Group

GxP Perspectives on twitter: @GxPPerspectives


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

====

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!


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.

====

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


%d bloggers like this: