Patient Assistance Programs are Consolidating

Written by Michael Milunec - Manager of Operations PDMA and Fulfillment Services, QPharma

Pharma’s Mergers & Acquisitions impact on Manufacturer provided Patient Assistances Programs

Looking back over the past decade, Pharma mergers and acquisitions (M&A) have been an ebb and flow relationship with 2009 being a tidal wave.  I am sure Pfizer /Wyeth, Merck/Schering-Plough and Roche/Genentech mergers were the number one contributing factors.   In a ten year M&A data review from DealSearchOnline.com, Pharma’s M&A hit a whopping 147.2 billion – translating into a 66% increase from the second highest M&A in that ten year span (2000-97.4 billion).[refer to chart below]

What does this mean for PAP?
Regardless of the reasons for companies consolidating with other companies (growing generic competition, shrinking drug pipeline, our Economy) the fact remains it is happening and that means a changing landscape for patient assistance programs.  As these mergers continue on patients, patient advocates, healthcare community will feel, to some extent, the pain before they feel the gain.  In this case the gain being greater program continuity.

When manufacturers merge together, many decisions relative to PAP programs need to be made.  Some of these considerations are if the program(s) will stay independent or if they will be consolidated?  Given the mega mergers mentioned above in all cases they consolidated all their support programs into and under one company with the exception of Roche keeping their ACCU-CHECK program in place.  Consolidating Patient Assistance programs is not an easy task.  here are many other considerations that need to be addressed such as standardizing enrollment rules, keeping the same medication(s) or even the same access points i.e. phone, IVR, web?  Furthermore, if these manufacturers outsource their programs (as most do) it now begs the question of which vendor to consolidate with and how comprehensive their program transition plan is so they do not leave patients behind or without medication.

As QPharma has been consolidating PAP programs for some time now, we have seen an increased need to ensure the client’s transition plan to address outdated access points, primarily on the web.  Furthermore not only should they address these avenues but there should be a monitoring program in place to ensure these points of access do not change or lead to a dead end, broken web-link or busy signal. 

To test my opinion, I applied our content site consolidation methodology as a hypothetical for the Pfizer/Wyeth PAP, a merger that happened over a year ago… and found that there were still some sites that think Wyeth exists as Wyeth as well as their assistance programs.  Furthermore, you can still get an outdated application form off them.  What is even more shocking to me is that one site in particular refers to themselves as a leading provider of online patient assistance. 

To conclude Companies are looking to acquire, consolidate and streamline their business and this will eventually lead to easier access points into those companies Patient Assistance Programs.  If I could be so bold as to make a future prediction regarding the Sanofi-Aventis/Genzyme consolidation I would say it could go one of two ways – Currently they are using 2 vendors between the both of them to run their programs, 18 all together.  One vendor provides services to both companies and the other vendor only provides services to Sanofi-Aventis.  I would implement an RFP proposal, engage other service providers not currently engaged, assess their price points, use these price points to negotiate new terms/pricing with the vendor who currently holds the most knowledge of both programs and establish service level agreements to ensure patients who utilize these programs are handled compassionately and receive their medication in a timely manner.   

Recommendations for an Effective Vendor Qualification Program - Part 2 of 2

Written by Teresa Jaworski – Subject Matter Expert, QPharma


In last week’s post, I shared with you some preliminary guidelines for qualifying a vendor. Here is Part 2 of that post:

Pre-Audit Questionnaire

If it is determined that a new vendor is needed, you should select a minimum of three (3) vendors, if possible, which can supply the product or services needed ( raw materials, components, manufacturing equipment, testing equipment, consulting services, etc.). The approved procedure should provide guidance for selecting these vendors. Once the potential vendors are selected, a pre-audit questionnaire should be provided to and completed by each of the potential vendors. The results from the completed questionnaire should be used to determine if the vendor will continue in the qualification process.


Onsite Vendor Audit


If it is determined that the potential vendor meets the criteria for continuing the qualification process per review of the completed questionnaire, schedule an initial, onsite audit as defined in the approved procedures.


When conducting the audit, the appropriate audit checklist should be used according to whether the vendor is defined as a critical or non-critical vendor. In addition, the onsite audit should include verification that the established requirements and specifications can be met by the vendor. Then based on the overall results, the potential vendor can be either accepted or rejected. If accepted, the vendor is considered qualified. If rejected, the company can either work with the vendor to resolve discrepancies and qualify the vendor or select another potential vendor. All auditing activities and results should be documented and maintained.


Quality Agreement


If it is determined that the vendor is qualified, a written Quality Agreement should be developed and approved between the company and the vendor. According to Hasselbalch, “a GMP guidance detailing expectations for quality agreements is in the works as well, and the regulations may be further upgraded to support the guidance in this area. The guidance will explain the expectation that the agreement be in writing and specify clearly what each party commits to do.”


Development and approval of the Quality Agreement should include members from all relevant areas within the company’s organization, including but not limited to quality, procurement, manufacturing, product development, process development, regulatory, and legal. This agreement should define required quality standards; products or services provided; quality requirements and specifications including but not limited to training, qualifications, and monitoring expectations; key contacts; quality roles and responsibilities; locations; and necessary communications regarding quality-related activities.

Recommendations for an Effective Vendor Qualification Program - Part 1 of 2

Written by Teresa Jaworski - Subject Matter Expert, QPharma

According to a June 16, 2010 article posted on the International Pharmaceutical Quality (IPQ) website, FDA Fast-Tracking Supply Chain cGMP Upgrades; Other GMP Changes, Quality Agreement Guidance Taking Shape, “FDA is fast-tracking a set of changes to 21 CFR Part 211 targeting control of raw materials, excipients and components used in pharmaceutical manufacturing.”

The Center for Drug Evaluation and Research (CDER) Office of Compliance Team Leader Brian Hasselbalch announced these impending GMP proposals at a Global Outsourcing Conference at Xavier University on June 14, emphasizing that “adulteration issues represent credible threats to our marketplace and that raw material controls have to be improved.”

Hasselbalch further explained “They will require drug producers to know who the original manufacturer is for all excipients and active ingredients, and any subsequent repackers and relabelers – that you know who they are, who handles [the material] in the supply chain, similarly to the EMA proposed pedigree.”

As discussed earlier in a September 2010 blog, the U.S. Food and Drug Administration (FDA) Guidance for Industry Q10 Pharmaceutical Quality System, which is in accordance with 21 CFR Part 820.50, specifies that Pharmaceutical companies are ultimately responsible for ensuring that processes are in place to assure the control of outsourced activities and quality.  We are now going to dig a little deeper to discuss how these controls can be accomplished.

A company should establish and implement processes that can determine the suitability and competence of a vendor for their specific needs.  These processes should include establishing approved procedures; performing audits; ensuring the vendor is qualified prior to selecting them as a vendor; and continuing to monitor the vendor’s performance after qualification including re-qualifying the vendor at established time intervals.

Establishing Approved Procedures

When establishing approved vendor qualification procedures, keep in mind that the procedures should include, at minimum, guidelines for the following:

• selecting a potential vendor for the products or services needed
• defining and documenting requirements and specifications to be met by the vendor
• determining whether the vendor is a critical or non-critical vendor
• auditing requirements for both a critical and non-critical vendor
• distributing the pre-audit questionnaire for completion by the potential vendor
• determining the vendor suitability as a result of the completed pre-audit questionnaire
• planning, scheduling and conducting on-site vendor audits
• preparing audit reports
• following up on any audit findings to ensure appropriate CAPAs have been implemented
• defining time intervals for re-qualifying/re-auditing vendor
• completing and maintaining vendor Quality Agreements
• developing and maintaining an Approved Vendor List
• storing all required vendor qualification documentation including pre-audit questionnaires, audit checklists and notes, audit reports, Quality Agreements, Approved Vendor List, etc.
• handling vendor relationships when requirements are no longer being met

It is also recommended that the following templates be included, or their location referenced, in the vendor qualification procedures to ensure consistency and to ensure that requirements are being met:

• Pre-audit Questionnaire, which should comprise requests for relevant information  such as the following:
• company name
• company location
• contact information (telephone, fax, email)
• company history
• product(s) or service(s) provided
• number of employees
• details of implemented quality systems
• dates of last regulatory audits (FDA, ISO, etc.)
• Audit Checklist for auditing critical vendors
• Audit Checklist for auditing non-critical vendors
• Audit Report
• Quality Agreement
• Approved Vendor List

Training should be conducted and documented on the approved procedures prior to being used, emphasizing the need for quality support during all phases of the vendor qualification process.

Stay tuned for Part 2, coming next Monday, November 15th!

FDA Announces Plans to Revise cGMP Regulations for Auditing Vendors

Written by Teresa Jaworski – Senior Validation Specialist at QPharma

By year end 2010, FDA is planning to release new regulations that will include requirements for Pharmaceutical manufacturers to physically audit their vendors, no longer allowing paper audits to be acceptable. This change is being considered because of the large number of gaps being found in manufacturers’ quality systems due in part to the growth of production outsourcing. It is expected that once the drafting process of these proposed regulations is completed, they will be available for review and comments for approximately three to six months.

Brian Hasselbalch

According to Brian Hasselbalch, representing the Office of Compliance’s Division for Manufacturing and Drug Product Quality within FDA’s Center for Drug Evaluation and Research, at a conference held jointly by the agency and Xavier University in Cincinnati, Ohio, June 13-16, “between 2001 and 2007, the number of products manufactured outside the United States and the number of manufacturing sites abroad doubled. Some of the new products being imported into the US come from countries with less developed regulatory systems.”

As indicated in the U.S. Food and Drug Administration (FDA) Guidance for Industry Q10 Pharmaceutical Quality System, which is in accordance with 21 CFR Part 820.50, Pharmaceutical companies are ultimately responsible for ensuring that processes are in place to assure the control of outsourced activities and quality. In doing so, companies should implement processes to access the suitability and competence of a vendor prior to outsourcing operations or selecting them as a vendor. This can be accomplished by establishing approved procedures, performing audits, and ensuring qualifications. Note that defined quality requirements should be used during the auditing process to ensure the vendor is capable of meeting these requirements. The evaluation results should be documented.

If it is determined that the vendor is qualified, an approved, written agreement, often referred to as a Quality Agreement, that defines quality requirements, responsibilities, and communications necessary for quality-related activities, should be created and approved between the two parties. Records of acceptable vendors should be established and maintained via an Approved Vendor List.

If a company does not have an Approved Vendor List, it cannot be concluded that vendors being used by the company are qualified to provide the products and services being used for cGxP purposes. With the establishment of an Approved Vendor List, a company can work smarter, not harder. A company will be able to determine if a qualified vendor is currently available that can provide the necessary products or services instead of going through the entire qualification process each time a new vendor is needed. It also ensures that several vendors are not being used for identical products or services. In the end, this will result in better utilization of resources, an improved state of regulatory compliance, and a cost reduction for the company.

However, having these procedures in place does not ensure proper implementation of them. Training should be conducted and documented on these approved procedures, emphasizing the need for quality in all aspects of the vendor qualification process including ensuring that all required vendor assessment and auditing documentation is stored in a centralized, secure location.

A vendor audit does not have to be conducted by a company representative. It is acceptable to use contracted resources to perform these audits as long as the resources are qualified to perform the tasks and the qualifications are documented. According to Hasselbalch, “We will not demand that you individually audit. We acknowledge and recognize a surrogate or a third party audit arrangement. It may be more efficient and more effective, quite honestly. A third party audit would have to be performed by a credible auditing arm [with] certain characteristics that assure the integrity and the quality of the audits.”

Refer to the links below for FDA MedWatch reports relevant to outsourcing.

• http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm172252.htm
• http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm214036.htm
• http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm214034.htm
• http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm213532.htm