Drug developers have found a powerful ally in their campaign to advance biosimilar adoption in the U.S. — the nation’s health insurance providers. Insurers are keen to drive down the price of reference biologics, and they view biosimilars as an important way to accomplish that goal.
Healthcare is undergoing a shift in how key stakeholders approach and evaluate patient data — driven by growing access to and general use of real-world data, such as de-identified patient data collected and analyzed from registries, electronic health records, wearable devices, and administrative and healthcare claims databases. This type of data is increasingly being utilized by industry representatives to help inform device development, health system operations, formularies and resulting coverage, and patient care decisions.
This article will address the expected roles of quality control and quality assurance, how these roles are related and how they are different, and how they must work together to create a sound quality management system (QMS).
Prescription drug spending increases — fueled by high launch prices for new therapies and price increases for existing brand-name drugs — are contributing to unsustainable healthcare cost growth across the country. In addition to straining the healthcare system overall, high drug prices also place financial burdens on patients who rely on prescription medicines to treat and manage serious and chronic medical conditions.
According to the FDA and other regulatory agencies, analytical instruments should be under the same strict control as manufacturing equipment. Analytical instruments provide critical scientific data about a manufactured product. This data ensures confidence that a quality product has been manufactured and is appropriate and safe for sale to the public. Therefore, as manufacturers, we are bound to ensuring all of our equipment is strictly controlled.
Typically, supplier management programs use a supplier survey or an on-site audit to verify if a supplier is compliant with the requirements of a standard or regulation. However, for a supplier management program to provide added value to an organization, the supplier evaluation should look beyond the requirements of a standard or regulation. A value-added supplier management program should also consider items such as supplier capability, capacity, and contingency planning.
How do we act on the data of previous 483s? What do we do with that data? Similar to the annual product reviews, we gather data on FDA observations, make graphs, and then … file it away. But there is an alternative.
In recent years, the growth in U.S. drug spending has become a hot-button issue. Data released in 2017 by the pharmacy benefit manager (PBM) Express Scripts illustrates which drugs account for the increased spending. In 2016, spend on so-called specialty drugs, a class that contains many biologics, grew by over 13 percent, while spend on traditional drugs actually declined by 1 percent. Five of the top 10 earning drug therapies in the U.S. in 2016 were biologics.
According to section 503B of the Food Drug and Cosmetic Act, outsourcing facilities are required to comply with all current good manufacturing practices (cGMPs) and regulations regarding insanitary conditions. Many regulatory observations are written for the failure to follow cGMPs and insanitary conditions. This article highlights some of the microbial expectations for 503B compounding pharmacies.