US-based contract manufacturer Ben Venue Laboratories (BVL) is to exit the CMO industry.
The unit, owned by Germany-based Boehringer Ingelheim, made its decision to pull out after drug regulator Health Canada’s recent assessment, which highlighted deficiencies in BVL’s good manufacturing practice (GMP).
As a result of the report, the board restricted import of several drugs made at BVL’s Ohio plant – which specializes in the production of injectable and inhaled drugs – including Torisel kidney-cancer treatment, manufactured for Pfizer.
Furthermore the board warned it will only allow the importation of drugs “deemed medically necessary” from the BVL site, and that the GMP deficiencies could have an impact on the quality of them.
In a letter issued to several hospitals, Health Canada acknowledged that the transaction is likely to cause a shortage of certain drugs in Canada.
Health Canada director general and health products and food branch inspectorate Diana Dowthwaite wrote: “Health Canada is advising Healthcare Professionals of a potential supply shortage of certain drugs currently available in Canada.
“The drugs affected are imported into Canada by a small number of companies from the contract manufacturer Ben Venue Laboratories Inc.”
“A recent assessment by Health Canada has identified deficiencies in the area of good manufacturing practices (GMP) at the BVL manufacturing site.
“In light of these deficiencies, Health Canada is allowing only the importation of drugs deemed medically necessary from the BVL site.
“These deficiencies may have an impact on product quality and have led to manufacturing capacity limitations which could affect the supply of medically necessary drugs imported into Canada.”
However, Boehringer-Ingelheim director of communications Duncan Cantor told Outsourcing-Pharma that the move is unrelated to the recent GMP issues.
He said: “I can confirm that Ben Venue will be withdrawing from the contract manufacturing industry and no, it isn’t anything to do with the GMP issue.”
Meanwhie, BVL associate director of communications & public relations Jason Kurtz said the company will now focus on simplifying its business model and will puts its energies into its Bedford Laboratories generics business.
He said: “We have begun the process of working with our customers to develop and implement comprehensive long-term transition plans in order to minimize potential impact of product supply.
“Throughout this transition process, our highest priority will remain the supply of medically necessary products for patients.
“Following the multi-year transition out of contract manufacturing, BVL will dedicate its facility to the manufacture of product for its Bedford Laboratories generic injectable business.”
The ripple effect
The implications of the new move – which will take place over several years, according to BVL spokesman Kurt – can be seen as far as America and Europe.
Pharmaceutical Research and Manufacturers of America (PhRMA) VP Karl Uhlendorf recently voiced his concerns about shortages in injectables.
And though he did not mention BVL directly, a “shift in clinical practices” and “individual company’s decisions to discontinue specific medicines” were ranked high in the list of reasons for the now rationed drug supplies.
He said: “America’s biopharmaceutical research companies are deeply concerned with patients’ well-being and their ability to get needed prescription medications.
“Their commitment to patients is evidenced by their tremendous investment in the discovery and development of new medicines.
“We cannot speculate about the causes of, or responses to, those generic drug shortages. However, shortages associated with brand-name medicines can be related to myriad factors, including shifts in clinical practices; wholesaler and pharmacy inventory practices; raw material shortages; changes in hospital and pharmacy contractual relationships with suppliers and wholesalers; adherence to distribution protocols mandated by the FDA; individual company decisions to discontinue specific medicines; natural disasters; and manufacturing challenges.”
Whilst European regulators have limited the import of drugs made at Ben Venue's plant.
Companies affected include Pfizer and Johnson & Johnson, who produces their Doxil treatment for ovarian cancer and multiple myeloma through BVL.
However J&J spokeswoman Lisa Vaga said the company will find another contract manufacturer during the transition period, and that Ben Venue has committed to giving highest priority to ensuring access to important drugs such as Doxil.
And a spokesperson for Pfizer told Outsourcing-Pharma the firm will continue to ensure patients have access to their BVL produced cancer treatment Torisel.
“Pfizer has been working with Health Canada to obtain approval for another manufacturer.
“Pfizer has a strong reputation for delivering high quality and safe products in a timely manner to patients in Canada.
“At this time, our priority is to ensure Torisel continues to be available in Canada. We are monitoring this situation to ensure that cancer patients continue to have access to Torisel.”