Three drugmakers with products in short supply have some homework to do, courtesy of a new House committee probe.
By sending letters to executives at Teva, Sandoz and Pfizer, Democratic members of the House Committee on Oversight and Accountability kicked off an investigation into three specific drug shortages that have been ongoing for more than a year.
The lawmakers asked detailed questions about the companies’ shortage responses and any related manufacturing issues. They gave the executives a March 6 deadline for written responses.
Sandoz received a letter centered on its amoxicillin shortage, while Teva was targeted for its Adderall shortage and Pfizer for its part in the oncology drug shortage.
The oncology drug shortage, for one, has been particularly severe since its start in early 2023, with up to 90% of hospital systems lacking consistent access to the meds at certain points, according to the committee’s letter (PDF) to Pfizer CEO Albert Bourla, Ph.D.
Since several generic cancer drug makers have been forced to discontinue production due to low profit margins, the lawmakers urged Pfizer to boost its output of certain medicines.
The company confirmed over email that it received the letter but offered “no further details” or comment at this time.
Sandoz, meanwhile, faces the lawmakers' questions as a major manufacturer of powdered amoxicillin, which has been in active shortage since October 2022. The powdered ingredient is used in the liquid form of the drug that’s commonly used to treat children.
The company, which officially spun out of Novartis last year, has had “several consecutive quarters of sales growth” but has “not addressed” the shortage, the lawmakers wrote in a letter (PDF) to the company’s president of North American operations, Keren Haruvi.
Sandoz in September attributed the supply strain to the same economic issues of low prices, which have forced some manufacturers to exit the market.
The Sandoz letter delved into a similar line of questioning as Pfizer's, questioning whether the company plans to increase its output to meet demand as others flee the market.
Sandoz “look[s] forward” to briefing the committee members on the work it has done to address the shortage as “we have a very strong story to tell,” a spokesperson said in an emailed statement.
As for Teva, CEO Richard Francis was questioned on the company's Adderall shortage, which has also been ongoing since October 2022. The FDA, in its original shortage notice, pointed a finger at Teva’s manufacturing delays as a main contributor to the supply woes.
Another factor in the Adderall shortage is its status as a controlled substance, which requires specific limitations on production. The Drug Enforcement Administration (DEA), however, has previously noted that some drugmakers did not produce the full allotment of drugs permitted under existing guidelines.
Teva was asked to explain this discrepancy in producing fewer drugs than its allotted quota in 2022 as well as to divulge the output numbers for 2023. The company did not respond to Fierce Pharma’s request for comment.
The investigation is far from the first action the government has taken on drug shortages. Late last year, Republicans on the House Committee on Energy and Commerce pressed the FDA for clarity on its tracking of scarce medicines and foreign inspection policies causing disruptions to the supply chain.
More recently, the American Society of Clinical Oncology testified at a House committee hearing on the issue.