Hikma paid nearly $85 million for the plant last year.
“For the time being, the Quality Development Center on the site is in active use,” a Hikma spokeswoman said in an email. “However, the rest of the site remains dormant for now and there are no plans to reactivate manufacturing at the site at this stage.”
Though the site’s problems at the start of the decade exacerbated a serious drug shortage crisis in the United States, the industry seems to have adjusted to the plant’s absence.
Drug shortages reached an all-time high in 2011, with 251 new drug shortages occurring, the US Food and Drug Administration said. That fell to 117 new shortages in 2012, 44 new shortages in 2013 and 44 as well in 2014. Though the FDA hasn’t said what the number is so far this year, it did say new shortages are occurring at a trend rate similar to the past two years.
That raises the question of whether the Bedford, Ohio, plant is even needed.
Erin Fox, director of the Drug Information Service at University of Utah Health Care, who’s closely followed the US drug shortage situation over the last few years, said some medications once made at the plant remain difficult to obtain, especially a few niche powdered chemotherapy products.
“We actually don’t have these products and some of our oncologists are scrambling,” Fox told BioPharma-Reporter.com. “They’d love to have them back again.”
Last month, the FDA approved Hikma’s thiotepa injection, a drug used to treat a variety of cancers. The product had been made at the Ben Venue plant, but since the plant closed had only been available as an import from an Italian company, and was challenging to obtain, Fox said.
Fox said it’s difficult, however, to fully assess the impact of the plant’s absence, noting that it experienced many problems even before 2010, “For all intents and purposes, it closed in 2010 and hadn’t made anything in years, so people tried to figure out work-arounds,” she said.
Because of all the problems it had over the years, it’s difficult to determine the closure’s impact on the industry. “It’s hard to know what the real capacity was, because it had shortages for so long and so much remediation,” Fox said.
Hikma bought the plant in 2014 after Ben Venue suspended almost all operations at the site in late 2013. The site includes four manufacturing plants, and at the time of the purchase, Hikma said the facility would allow the company to “significantly advance our R&D capabilities and enable us to expand future capacity.”
Last year, Hikma told investors it planned to transfer much of the equipment from the plant to the company’s other facilities, including one in Cherry Hill, New Jersey. Some of the equipment it planned to move included lyophilizers, to enhance its cytotoxic capabilities. At that time, it said it had saw no need to reactivate the Ben Venue facility, which is one of the largest sterile injectable sites in the world.
In Bedford, City Manager Michael Mallis wishes the jobs the plant used to bring would come back.
“From a city of Bedford standpoint, with Ben Venue having at one point 1,300 employees, we’d love to get employees back,” Mallis said. “It is our goal and wish that manufacturing does return to Bedford. We do have a very solid, growing working relationship with representatives from Hikma and they know we’re here to assist them in any way possible. We’re going to take it one day at a time, one week at a time, one month at a time and see where it goes from there.”