Quality systems for prescription medicines are – by necessity – extremely robust. Ensuring compliance and staying up to date with changing quality metrics can pose a variety of challenges –from API scrutiny and distribution quality to data integrity issues and supply chain uncertainties.
Although over the counter (OTC) drugs have lower quality thresholds to meet before they can go to market, a growing number of manufacturers are looking beyond regulations and best practices.
They recognize the hazards of cutting corners and the value of ensuring that all their products meet the highest common denominator for quality.
OTC Formulation: Extra Expense or Smart Investment?
Margins are often razor-thin in the OTC market. It’s no surprise that many companies working with contract development and manufacturing (CDMO) partners are reluctant to budget for the kind of formulation development work that’s routinely performed for prescription medicines.
It’s also remarkably easy to find manufacturing operations that appear economical because they only produce OTC products. The adage ‘you get what you pay for’ is relevant in these cases, but perhaps more important is the corollary: ‘you don’t get what you don’t pay for.’ A drug company will undoubtedly know the strength of an API in a formulation, along with the inactive ingredients used, but they may not be aware of – or own – the quantitative formula.
Many companies that specialize in OTC medications keep their costs structures low by not charging up-front development fees. That’s often a red flag, because those same organizations also tend to have less-robust quality systems and processes in place, given the lower regulatory thresholds for OTC drugs.
The Costs of Cutting Corners
As tempting as it may be to bypass the cost of formulation development, it’s a critically important part of the process. It not only identifies the concentration of the active ingredients but also the concentration of other ingredients and, in most cases, a recommended procedure for mixing the formulation. When done right, formulation work quickly pays for itself by mitigating or eliminating many of the problems OTC companies face with the FDA, or with quality issues in general.
For example: a century-old U.S.-based OTC brand recently found itself struggling with a manufacturer that failed to successfully complete the formulation development process.
As a result, they shifted their strategy, and now make development work a standard part of their process. It’s been a huge shift for them, but it only took one bad experience for them to recognize the value.
Their experience is fairly common, and recent incidents in the OTC space have further highlighted potential hazards. Criminal prosecutions are currently underway for multiple senior executives at one company known for low-cost manufacturing. When the DEA raided the facility and seized assets, it was discovered that the organization didn’t have adequate security systems in place. Allegations have been raised that millions of doses of opiates may have been mis-distributed. The company’s assets were eventually purchased at fire-sale prices, but by that time multiple clients had gone scrambling to find alternative partners with higher quality standards.
At least two other manufacturers are also trying to sever ties with another low-cost company as quickly as possible. Their supplier just received a stern warning from the FDA because of significant quality failures.
Quality failures are a huge risk, and lack of formulation portability further compounds that risk. Drug companies who fail to invest in formulation development have considerably less flexibility if their current manufacturer isn’t able to deliver on time – or worse, runs into trouble with regulators. If they don’t own the formulation, this could force a drug company to start from scratch.
So how do you ensure the highest possible quality without breaking the bank?
Balancing Cost and Quality
As we’ve already shown, prioritizing price over quality can be risky business. We’ve seen this play out multiple times over the years, as customers have shifted to bargain-basement OTC contract manufacturers only to return when quality-related incidents, warning letters, and other disruptions became a persistent threat.
A better option is to manage the process as efficiently as possible. At LGM Pharma, we start with a risk assessment, informed by our history with similar types of formulations, to determine what approach will deliver the optimal balance between cost and quality.
As part of our commitment to excellence and industry leadership, we approach the quality of over-the-counter drugs with the same standards we use for prescription formulations. We utilize the same key performance indicators (KPIs) and quality management systems to monitor performance and drive continuous improvements.
It is also a standard part of our process to exceed regulatory standards for all medication categories. This ensures our readiness for future regulatory changes while enabling us to measure and achieve higher standards today.
Discover how LGM Pharma’s Formulation Services can help ensure the quality of your OTC drug.
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