Two drugs contract-manufactured by Ben Venue are now in short supply after the firm voluntarily shut down its Bedford, Ohio plant in November to investigate quality and manufacturing issues highlighted in recent FDA and EMA inspections.
Doxil – marketed by New Brunswick, New Jersey-based Johnson & Johnson and used to treat ovarian cancer, multiple myeloma and other cancers – has been in short supply since June. J&J announced at that time the “supply situation has been caused, in part, by unplanned downtime due to equipment failures at our independent specialty manufacturer.” The shortage situation has been exacerbated by Ben Venue’s subsequent shut down.
Those patients who are active and enrolled in J&J’s “DOXIL C.A.R.E.S. Physician Access Program” will continue to receive the full course of therapy that has been allocated and set aside specifically for them, according to a company announcement. J&J maintains a list of patients waiting to begin the therapy, which reportedly numbers over 2,000.
The other drug – Vibativ – is an injectable medicine used to treat Gram-positive infections such as methicillin-resistant Staphylococcus aureus (MRSA). Vibativ was developed by South San Francisco, California-based Theravance and is marketed in the US by Astellas Pharma headquartered in Deerfield, Illinois.
In a Securities and Exchange Commission (SEC) filing in early December, Theravance included a letter sent by Astellas on December 2 to wholesalers, distributors and healthcare professionals advising them that it is placing a hold on distribution of Vibativ while the manufacturer investigates its “production equipment and processes.” Astellas states in the communication that “the duration of the distribution hold is difficult to predict and has now resulted in critical product shortages and regional supply outages.”
Although the product is not being withdrawn from the market, Astellas recommends to healthcare providers that “patients not be initiated on Vibativ therapy unless sufficient supply is available at your institution.” Astellas added that it is unaware of any adverse reactions or safety issues with the drug related to manufacturing issues.
In late November, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended a recall of three drugs used in cancer therapy following an FDA inspection of Ben Venue’s Bedford facility and a subsequent European agency inspection, both of which highlighted numerous quality assurance problems in the firm’s manufacture of sterile injectable products (IPQ “In the News” November 29, 2011).[/membership]