Those savings are typically passed on to the patient who, after several generic versions of a single drug hit the market, will pay up to 80 percent less. The more generics competing against each other to sell a single drug, the lower the price; hence Gottlieb’s push to get more of the copycat drugs to market.
Prices remains a key interest of the Trump administration, and in recent weeks Congress has introduced several bills to contain them.
The issues with data integrity at companies in India and China—and now in the U.S.—raise questions about whether the drugs actually work the way they’re intended.
There’s no easy way to measure the scope of the problem. Drugs are recalled every day for various reasons. Cases of contamination are sometimes easier for distributors or patients to spot. With other issues, including the rate a drug dissolves in the body or whether a medicine contains enough active ingredient, the FDA typically counts on the drugmaker to identify a problem and then relay it to the agency.
In fact, the FDA doesn’t test finished drugs or ingredients regularly, relying heavily on company testing. If manufacturers are omitting data that show quality testing failed, that information might not get to the FDA.
An online-pharmacy startup in New Haven, Connecticut, called Valisure tests the medications it dispenses. Since opening last year, it has screened about 100 drugs and found that more than 10 percent didn’t have the proper amount of active ingredient or didn’t dissolve as they should, according to David Light, Valisure’s chief executive officer.
In the case of Mylan’s West Virginia facility, the FDA inspected again in 2018, in March and April. Inspectors made a list of 13 alleged violations, including that Mylan’s manufacturing equipment wasn’t cleaned at appropriate intervals to prevent contamination. Inspectors also found that Mylan’s attempt to address the purported violations involving prohibited trial testing from the agency’s November 2016 visit was “not adequate,” though the reasons why are redacted from inspection documents.
In its earnings statement issued in November, Mylan said it had committed to a “restructuring and remediation program” to reduce complexity at the site by decreasing the number of products made there and reducing the workforce. Four days later, the FDA sent Mylan a warning letter for its West Virginia plant. This time, the agency told the company to hire a manufacturing consultant to help the plant improve its standards.
“We are working closely with the agency to resolve all of their concerns,” Mylan said in an emailed statement. “The facility continues to manufacture currently approved products while we are executing on our commitments to FDA. Mylan is committed to maintaining high quality standards, and we take very seriously our continued and comprehensive oversight of our entire manufacturing network.”
Mylan also said the FDA conducted 21 inspections at its almost 50 facilities around the world in 2018. The company sells more than 7,500 brand-name and generic prescription drugs and over-the-counter treatments.