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As Americans become more concerned about quality issues with prescription medications made abroad, one company is trying to offer an additional layer of reassurance -- by doing chemical analysis before dispensing drugs to patients.
Valisure launched just over a year ago, positioning itself as a pharmacy, a lab, and a wholesaler. Now licensed in 38 states and with a staff of 25 in Yale University's Science Park in New Haven, Connecticut, Valisure analyzes some 2,000 drug products -- mostly generics, but also some brands -- to introduce an additional level of quality control into the system.
"We thought, wouldn't it be great to have chemical analysis at the end of the supply chain, here in the U.S. where it matters the most, when patients are going to get the drug," Valisure Founder and CEO David Light told 鶹ý in an interview.
Valisure has already made an impact on the pharmaceutical supply chain. The company identified a , proffered evidence that ranitidine degraded into NDMA, and now is raising alarms about contaminated metformin. In each case, the company and also filed citizen petitions with the FDA requesting recalls.
"The fact that we found so many big problems within about a year of launching our pharmacy underscores that it's really needed," Light said. "Nobody has been doing this third-party check."
Getting Started
Back in 2015, Light's friend and company co-founder Adam Clark-Joseph, PhD, told him about . Every now and then, Clark-Joseph wouldn't feel good on the meds, or he'd have side effects or relapses. His doctors told him that was typical, since most drugs were made in India or China and there wasn't much that could be done about the variability.
Light was familiar with some of the challenges in the global drug supply chain given his molecular biology degree from Yale and having worked at startups including Synthetic Genomics and Ion Torrent. He knew that companies self-reported the quality of their drugs to FDA, and agency inspections typically involved checking the facility itself, but not the chemistry of the medications beyond the tests required for approval.
So Light and his co-founder put up their own money and spent a few years developing a new system for chemical analysis of medications, ending up with a Raman spectroscopy method that they say is both fast and accurate. The company filed patents on its technology and secured for their laboratory.
The FDA told Valisure the company is the only pharmacy that's attached to an analytical laboratory, Light said.
How It Works
Like any U.S. pharmacy, Valisure buys drugs from approved U.S. distributors; the difference is that these distributors allow the company to sample any batch before they purchase it.
Light says the strategy is based on evidence that quality is consistent within batches, but can vary from batch to batch: "We've seen with same manufacturer completely clean lots, then another lot comes along and who knows what happened, but the quality is very different."
Valisure checks not only for contaminants, but also for correct dosage, issues with inactive ingredients, and dissolution problems. While the company borrows largely from industry standards, Valisure charts its own course if the metrics "don't make scientific or physiological sense."
For example, the industry standard for dissolution uses a very potent solvent, Light said. "This solution does dissolve the pill really well. I mean, it would dissolve your hand well," he quipped. "But it's obviously not indicative of what's happening in the body. The product may pass in this absurd scientific scenario, but we don't test it that way." (Valisure and the FDA had a public spat last fall over assay methods involving nitrosamines and ranitidine.)
If Valisure is satisfied that the drug is high-quality and uncontaminated, it'll go ahead and buy it in large quantities, such as a 6-month supply. That's distinct from standard pharmacies, which typically buy daily or weekly in order to save money, Light said.
Light says the company has rejected over 10% of the batches it's sampled, and the FDA has asked Valisure to share information on rejected batches with drugmakers.
Business Model
Valisure's marketing is targeted to individual patients and doctors, but the company is also working higher up the healthcare chain, looking to act as a wholesale partner to hospitals and health systems. Light says the idea is to focus on key drugs that are often a pain point for hospitals.
The company has also launched a partnership with a pharmacy benefits manager called CapitalRx, and recently signed on to a collaboration with GovZilla, a company focused on artificial intelligence in the regulatory sphere.
With GovZilla, Valisure will work to create quality scores, ranking manufacturers according to their chemistry quality data. The idea is for health systems to have additional information, beyond just price and availability, when buying medications.
Valisure is privately owned, so data on revenue and customers aren't available. But Light says the time is right for his company to shake up the market.
"Consumers are increasingly engaged, vigilant and careful about everything they put into their body. Whether the consumer is an individual or a hospital with a billion-dollar pharmacy, no one has any information about the quality of what they're getting," Light said. "We're paying more for healthcare than ever before, so we're also paying attention to our dollars. What are we actually paying for? The health system is feeling that pressure even more. What are they reimbursing? Is it effective?"
That pressure will only intensify as the coronavirus outbreak further disrupts pharmaceutical supply chains, Light said, leading to more questions about the purity of medications in a system that's already struggling with consumer trust.
Mahmud Hassan, PhD, MBA, a healthcare economist at Rutgers University in New Jersey, acknowledged the growing fears in the U.S. about the quality of prescription drugs and said Valisure's approach could be a timely strategy to allay those concerns.
"People are scared, nowadays, of drugs coming from China, India. There's a bad record there," Hassan told 鶹ý. "This country needs a much safer method of getting drug supplies. I think safety is a good strategy, and [hospital systems] may give this a shot, if this will increase trust in the market."