Ranbaxy to Shed as Many as 400 Middle and Senior Management Jobs

Posted in BioBusiness

The UK’s Economic Times reported  today that the troubled Indian generic drug manufacturer Ranbaxy may shed as many as 400 jobs from its various divisions. Most of the persons receiving pink slips will be senior and middle management who are likely losing their jobs because of ongoing serious drug manufacturing problems that have plagued the company for over three years.  The drug maker employs about 14, 600 people in 43 countries.

While the job cuts do not represent a significant percentage of Ranbaxy’s workforce, Daiichi Sankyo which owns the company, is likely eliminating members of the management team that have been responsible for the company’s ongoing manufacturing problems. According to the Economic Times article

“On Thursday, some senior executives from the finance department at Ranbaxy were asked to leave. On Friday, some senior executives from the Research & Development wing were given marching orders,” an employee familiar with the job cuts told ET. Another executive said some officials from the API(active pharma ingredient) division have also been handed pink slips.

This past May, Ranbaxy paid the US Department of Justice $500 million to settle criminal and civil charges to resolve the manufacturing problems that prompted the US Food and Drug Administration (FDA) to ban the sale of dozens of drugs manufactured by the company.  More recently, FDA inspectors issued an unsatisfactory inspection report for one of the company’s manufacturing plants in India.

Ranbaxy is one of the world’s leading generic drug manufactures and the company’s ongoing manufacturing problems have certainly hurt Daiichi Sankyo’s image. Also, it has led some analyst to question whether or not Daiichi Sankyo ought to have purchased the troubled generic manufacturer for $4.6 billion in 2008.

Until next time…

Good Luck and Good Job Hunting!!!!!!

FDA and Social Media: Much Ado About Nothing

Posted in Social Media, Uncategorized

Since the inception of blogs, Facebook, Twitter, YouTube and other social media platforms, many life sciences companies, mainly big pharma, have been anxiously awaiting regulatory guidance from the US Food and Drug Administration on how to use them. Interestingly, FDA did issue some guidance in 2012 on it use last year but many drugmakers felt that it was insufficient and not detailed enough.  Despite the lack of clearly defined regulatory guidance, many companies took the social media plunge anyway. And according to a recent survey of regulatory actions and letters conducted by Mark Senak author of the fabulous EyeonFDA Blog the agency has done very little to thwart the social media strategies implemented by drug companies. In fact, there has been no obvious increase in the number of warning letters or violation letters regarding the use of digital or social media as compared with traditional media violations.

Senak drew this conclusion after analyzing 173 warning and notice of violation letters (advertising and media related) that were issued by the agency from 2008 to 2012.  Of the 173 regulatory letters that were issued, 675 violations were cited and only 43% involved digital media.  And, for the most part, most of the cited violation had little to do with the digital or social media vehicle used but more to do with the message being delivered. For the full report click here.

What does this all mean? While it is difficult to draw any firm conclusion, I believe that the bottom line is that the importance and significant of the long awaited FDA guidance on the use of social media has been overstated. Put simply, if you follow the existing rules guiding advertising and print media, companies ought to be able to craft a regulatory-compliant social media communication strategy without the fear of running afoul of the agency.  Those who violate the existing rules will likely be caught and have to clean up their acts.

The bottom line. Many drug companies have been able to mount very effective social media campaigns without getting into trouble with FDA.  The key to success is following the rules and implementing a digital/social media campaign that has passed internal regulatory muster to insure that everything is in order and regulatory compliant. Companies that have made the investment into digital/social media will be successful whereas others that jump into the game without taking the time to understand the rules of engagement will fail.

Until next time…

Good Luck and Good Job Hunting!!!!

 

 

Regulatory Affairs Update; FDA 483 and Warning Letters Trends for 2012

Posted in BioEducation

Those of you who manufacture products approved by the US Food and Drug Administration (FDA) are well aware of the importance of complying with Current Good Manufacturing Practices (cGMP) during FDA mandated inspections of your manufacturing facilities. Failure to comply with cGMP requirements during an inspections results in the issuance of 483s. And if you fail to adequately address the concerns of the agency outlined in 483s, it may ultimately result in issuance of warning letter to your company.

FDA is more vigilant and aggressive than ever before with its 483 and warning letter enforcement procedures. In the words of Commissioner Margaret Hamburg, FDA is quick, visible and vigilant.  With this in mind, it may be worthwhile to participate in a webinar offered by Expert Briefings.com entitled “Top Compliance Trends for 483 and Warning Letters for 2012—Based on Rare FDA Data.”

The webinar will be held on March 8, 2012 from 2:00-3:30 PM EST and Dennis Moore, Managing Partner, AUK Technical Services and a 28 year veteran FDA investigator will lead it. 

Topics to be covered include:

  • Top warning letter trends for 2012, such as more 806 enforcement
  • The Top 10 QS 483 Observations for 2010 and 2011
  • Most common quality system failures for drugs for 2010
  • Top drug and device citations in 483s for 2010
  • Top drug and device warning letter citations for 2010
  • Total 2010 BIMO inspections for CDER, CBER, CDRH, and CVM
  • Details on clinical investigator, sponsor/monitor and IRB audits for 2010
  • Most common sponsor deficiencies for 2010
  • The rising trend of ‘cease to market’ letters, one of which hit a NY pharma company in 2011
  • The total number of 483s issued in 2010 and 2011 – an all time high
  • Total CAPA 483 observations in 2010
  • How long to receive a warning letter, based upon which offices issues it
  • 483 inspection targets for drugs and devices for 2010, 2011, and 2012
  • Total warning letters issued by drug and device category in 2010
  • Which district offices write the most warning letters
  • How long to receive a warning letter, based upon issuing office
  • Warning letters issued by QS system for 2010
  • 483s broken down by QS subsystem for 2010
  • Warning letters by CFR section
  • Top device 483 observations for 2010
  • Details on process validation observations for 2010
  • Design control 483 observations by category for 2010
  • Click here to visit Expertbriefings.com.

Click here to visit Expertbriefings.com.

I hope to see (hear ?) you at the webinar!

 

FDA Inspections: Insights into Responding to FDA Inspectional Observations

Posted in BioBusiness

US Food and Drug Administration (FDA) inspections of drug and devices manufacturing facilities are typically anxiety ridden exercises that can strike fear into even the most seasoned quality and regulatory affairs professionals. And, most manufacturing facilities do not escape these inspections unscathed and are routinely cited, in many cases, for minor infractions.

For those of you who may not be familiar with FDA inspections, manufacturing facilities that produce approved drugs and devices must be inspected every two years for insure regulatory compliance with Current Good Manufacturing Practices (CGMPs). During the inspection, FDA inspectors document “significant objectionable conditions, relating to products and/or processes or other violations of the Food Drug and Cosmetic Act” that they observe. These are known in the industry as Form FDA 483 Inspectional Observations or simply 483. Companies that receive 483s must correct the so-called objections conditions to remain CGMP compliant.

While receiving 483s during an inspection may be routine, it can be overwhelming to inexperienced companies and their representatives. With this in mind, I found a great blog post by Bruce McDuffee, Global Marketing Manager, Veriteq that provides insights on interacting with the agency to manage 483s. He offers the following advice:

“One thing that you should be clear about is that this is not a ‘warning letter’; it is an offer to help you resolve issues and improve your quality system. The FDA may or may not issue a warning letter next if you have not addressed the conditions of the 483 to its satisfaction. Receiving a 483 does not necessarily mean you are out of compliance.

In responding to a 483, your objectives should include these three things; establish credibility, demonstrate acknowledgement and understanding of the observations and the associated requirements and show commitment to corrective actions."

Bruce recommends that you take the following actions when dealing with 483s:

  1. Get your response in on time or even early if possible. The FDA wants to see the response within 15 days, so plan your review and internal processes accordingly.
  2. In the first paragraph, demonstrate your understanding of and desire to comply with FDA regulations.
  3. Respond individually to each item addressed on the form. Give a corrective action and time-frame for implementing.
  4. Prioritize by first addressing the conditions that will most likely affect product quality.
  5. Outline how and when each deficiency will be corrected.
  6. Avoid talking about whose fault the issue is or how it came to be. For example, keep a positive tone and indicate how the quality system will be improved.
  7. Include any reference documents, such as purchase agreements for a new monitoring system or employment agreement for a new quality manager.
  8. Keep in mind that there is a formal process available for you to dispute the findings.
  9. Be proactive in addressing the conditions. For example, address why the deficiencies were not detected internally and what will be done to correct this condition.
  10. Seek clarification with the inspector when you receive the 483 on the spot. Be sure you understand each objectionable condition before the inspector leaves the site. It may behoove you and your firm to seek out an industry expert if the matters seem complex or if the issues are not able to be resolved by your own personnel.”

While CGMP and regulatory compliance may seem like arcane concepts, they are vitally important and must be clearly understood by companies that are manufacturing FDA-approved drugs and devices. Failure to comply can result in penalties, monetary fines and revocation of a license to manufacture a drug or device.

Until next time….

Good Luck and Good Job Hunting (try regulatory affairs or quality assurance and control)