Angie Drakulich was editorial director of Pharmaceutical Technology.

Angie Drakulich

	Deviations happen. FDA recognizes this and requires deviations to be investigated and documented, say Peter Smith and David Elder. The former senior FDA officials are both in strategic compliance consulting at Parexel. When performing a deviation investigation, FDA expects certain things.

	For starters, the investigation report must be designed for the reader, providing information and evidence that fully support the findings, conclusions, and actions. The report should relate a story that can be clearly understood by a third party months or even years after the event and the investigation. Read 

 from Smith and Elder in the May issue of PharmTech.

Articles

Deviations happen. FDA recognizes this and requires deviations to be investigated and documented, say Peter Smith and David Elder. The former senior FDA officials are both in strategic compliance consulting at Parexel. When performing a deviation investigation, FDA expects certain things.

How to Prepare a Deviation Investigation Report

		On Sept. 12, 2012, the Pharmaceutical Research and Manufacturers of America (PhRMA) is cohosting a brand new national awards program at the Newseum in Washington, DC, to honor individuals and organizations who have contributed significantly to the advancement of patient care and medical innovation in the United States.  The new annual awards, called the Research and Hope Awards, are replacing PhRMA’s Discover’s Award, and this year, will focus on the fight against Alzheimer’s Disease. The Alzheimer’s Foundation of America, the National Alliance for Caregiving, and the National Association for Home Care & Hospice are cohosting the 2012 event.

 is a media partner to the awards, which will be given in the following categories, according to PhRMA:

			The Research & Hope Award for Academic Research in Alzheimer’s: Presented to individuals or a team from the academic community for outstanding research in the search for a cure of Alzheimer’s disease

			The Research & Hope Award for Biopharmaceutical Industry Research in Alzheimer’s: Presented to individuals or team from a biopharmaceutical company for outstanding research in the search for a cure for Alzheimer’s disease

			The Research & Hope Award for Patient Advocacy: This award is presented to an individual or organization that has had significant impact supporting and advocating for legislative or regulatory health policy issues. Their work has increased awareness, funding for research or access to care. The award recognizes the involvement, commitment and achievement to the fight against Alzheimer’s.

			The Research & Hope Award: Volunteer Champion: This award is presented to an individual who has significantly affected the lives of patients and/or home caregivers in a charitable or humanitarian way. The Volunteer Champion recognizes individuals and caregivers who give selflessly to help other in need.

		The science award winners are being selected by a special committee of the PhRMA Foundation. The advocacy awards are being selected by a committee made up of PhRMA and cohost representatives. Look for interviews with the winners here after the ceremony. 

On Sept. 12, 2012, the Pharmaceutical Research and Manufacturers of America (PhRMA) is cohosting a brand new national awards program at the Newseum in Washington, DC, to honor individuals and organizations who have contributed significantly to the advancement of patient care and medical innovation in the United States.

PhRMA Research Awards Focus on Alzheimers Disease

	Finding an effective and fully compliant change management system that works is not easy. And yet, regulators look for one. Here are a few tips from Peter Smith, in Strategic Compliance Consulting at PAREXEL International, on how to deal with common change management problems such as assessments and documentation of the change. Smith is a former senior official with FDA.

	For starters, do not use “planned deviations.” Many companies use the erroneous concept of “planned deviations,” which are not deviations at all, but rather, changes. These changes are often temporary and handled within the deviation management system or similar program. Deviations are unexpected events wherein some control is lost and the product quality impact of the event must be evaluated retrospectively. No one wants to “plan to deviate” and deviations raise a red flag to regulators…. Read the rest of the 

Change Management: How to Deal
Published by Angie Drakulich on August 14, 2012 02:19 pm under Regulation
Finding an effective and fully compliant change management system that works is not easy.

Change Management: How to Deal

On Sept. 12, 2012, the Pharmaceutical Research and Manufacturers of America (PhRMA) is cohosting a brand new national awards program at the Newseum in Washington, DC, to honor individuals and organizations who have contributed significantly to the advancement of patient care and medical innovation in the US. The new annual awards, called the Research and Hope Awards, are replacing PhRMA’s Discoverer’s Award, and this year, will focus on the fight against Alzheimer’s Disease. The Alzheimer's Foundation of America, the National Alliance for Caregiving, and the National Association for Home Care & Hospice are cohosting the 2012 event. 

The Research & Hope Award for Academic Research in Alzheimer's: Presented to individuals or a team from the academic community for outstanding research in the search for a cure for Alzheimer's disease

The Research & Hope Award for Biopharmaceutical Industry Research in Alzheimer's: Presented to individuals or team from a biopharmaceutical company for outstanding research in the search for a cure for Alzheimer's disease

The Research & Hope Award for Patient Advocacy: This award is presented to an individual or organization that has had significant impact supporting and advocating for legislative or regulatory health policy issues. Their work has increased awareness, funding for research, or access to care. The award recognizes the involvement, commitment, and achievement to the fight against Alzheimer's.

The Research & Hope Award: Volunteer Champion: This award is presented to an individual who has significantly affected the lives of patients and/or home caregivers in a charitable or humanitarian way. The Volunteer Champion recognizes individuals and caregivers who give selflessly to help others in need.

“This award ceremony celebrates the evolution of research and progress made in the battle against such a complex and devastating disease. Yet, despite the enormous challenges biopharmaceutical scientists continue to face fighting Alzheimer’s, the achievements we will be recognizing give us hope,” said John J. Castellani, president and CEO of PhRMA. “This is also an opportunity to better recognize those individuals who have devoted their lives to helping patients suffering from such a debilitating disease.”

The science award winners are being selected by a special committee of the PhRMA Foundation. The advocacy awards are being selected by a committee made up of PhRMA and cohost representatives. Interviews with the winners will appear in the December 2012 issue of 

. For more information, visit the PhRMA Awards 

On Sept. 12, 2012, PhRMA is cohosting a brand new national awards program in Washington, DC, to honor individuals and organizations that have contributed significantly to the fight against Alzheimer's Disease.

PhRMA Research Awards Focus on Alzheimer's Disease

	Just about a year ago, in July 2011, FDA published a roadmap for addressing the challenges of globalization. The roadmap, “Pathway to Global Product Safety and Quality,” was based on four core building blocks: with a global coalition of regulators, build and strengthen the product safety net around the world; develop a global data-information system; expand intelligence gathering and use, focused on risk analytics and modernized IT; leverage and prioritize resources based on risk.

	In the years ahead, the worldwide industry should expect to see: improved consistency among regulatory inspections; inspections that are well-informed by global issues affecting product quality, safety, or efficacy; enhanced recognition and reliance upon the regulatory inspections conducted by recognized health authorities, which may reduce the total number of regulatory inspections at any one site but also increase the impact of each inspection.

	Regardless of which health authority conducts the inspection, the preparation for, and management of, the inspection process is quite similar. Whether it’s a surveillance, pre-approval, or for-cause inspection, regulatory inspections are crucial activities that affect business success on several levels. David Elder at PAREXEL Consulting, a former FDA official, advocates a few key steps to prepare for and manage an inspection.  Read his tips 

Just about a year ago, in July 2011, FDA published a roadmap for addressing the challenges of globalization

Inspections on the Rise. Get Prepared.

At the beginning of each month, I get an automatic email notification from FDA noting the latest drug shortages that exist in the US market. As of early June, there were about 130 product types listed on FDA's drug-shortage webpage. Most of the affected products are cancer medications, anesthetics used for patients undergoing surgery, emergency medications, and intravenous electrolytes. Sterile injectables dominate the list and are prime targets for shortages because of limited production lines and capacity challenges, explains the FDA webpage. The reasons given for the various shortages include everything from manufacturing delays to increased market demand to material (API) shortage to product discontinuation. 

FDA points out that shortage information is provided "voluntarily by manufacturers" and that the agency "cannot require firms to report the reason for shortage or duration of the shortage or any other information about shortages." This may soon change however. Earlier this year, FDA issued a draft guidance, 

Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage.

 The guidance is meant to address growing concerns about drug shortages, which have tripled from 61 in 2005 to 178 in 2011, states the draft guidance. In 2011, FDA tracked over 250 drug shortages. These shortages can prevent patients from getting the crucial medications they need, when they need them. In addition, shortages can lead to larger problems. For example, in late May, FDA warned the public about a counterfeit version of Adderall being sold on the Internet—the counterfeit version contained the incorrect API. The drug just happens to be on the shortage list due to API supply issues. 

Although the agency cannot do anything to stop drugs from being discontinued—that is the manufacturer's choice—it can do something about supply and quality problems that lead to shortages and about the way shortages are reported and tracked. A goal of the guidance is therefore to increase communication between industry and regulators in an effort to protect the public health. Reporting planned discontinuations of life-saving drug products to the authorities has been a requirement of manufacturers since about 1997 under Section 506C of the Food, Drug, and Cosmetic Act. However, the new draft guidance goes further by clarifying who has responsibility for such reporting: the "sole manufacturer," defined by the draft guidance as "the only applicant currently supplying the US market with the drug product" where drug product includes specific strength, dosage form, and route of administration. The draft guidance also redefines the term "discontinuance" to include "any interruption of manufacturing of a drug product described in paragraph (b)(3)(iii)(a) for sale in the United States that could lead to a potential disruption in supply of the drug product, whether the interruption is intended to be temporary or permanent." 

In October 2011, FDA reminded manufacturers 

 letter of their mandatory reporting requirement and encouraging them to voluntarily report any disruptions in supply that could lead to a product shortage. That same month, President Obama ordered FDA to "use all available administrative tools to expand the Agency's efforts to combat the problem of drug shortages." The new draft guidance aims to carry out that order and to further enforce Section 506C. The draft document specifically calls out certain actions that may lead to a temporary or permanent drug supply problem, such as delays in acquiring active or inactive ingredients, equipment failures, and manufacturing shutdowns, whether for maintenance or routine matters. Manufacturers will need to notify FDA of these issues if they could lead to a disruption in supply. The agency also asks industry in the draft guidance to notify it on a voluntary basis (the above items would be mandatory with the final guidance) when certain problems could "reasonably" be expected to lead to a drug shortage or disruption (e.g., stability concerns, facility transfer, etc.) 

I have high hopes for the guidance. In 2010, for example, 38 shortages were prevented because companies notified the agency of potential problems. Just as we tell our children, it's always best to tell the truth—even if it hurts a little to do so—because in the end, it's simply the right thing to do. 

Comments on the FDA draft guidance were due at the end of May 2012. According to the FDA press office, 16 comments were submitted and a final guidance is expected to be issued promptly. In the meantime, companies and suppliers can send relevant shortage information to 

Manufacturers willing to report bad news about the supply can help reverse the shortage trend.