Over the years, the pharma industry has made headlines with their talk of developing futuristic drugs. The FDA has also actively shown support by working with various pharmaceutical companies to develop medication and modes of treatments that are designed specifically to address the issues that patients face.
However, despite the sparkling innovation that pharma shows in brainstorming and R&D procedures, they don’t show as much attention to detail in their manufacturing process. In fact, this is one area which often gets overlooked, much to the surprise of many industry experts.
Really Not Up to Standards
The fact that drug manufacturing is lagging isn’t something new for the pharma industry. In 2003, a scathing article in the Wall Street Journal noted that while the pharma industry is breaking boundaries in the development of new drugs, the manufacturing process of most companies often lacks the same finesse and standards.
A comparison showed that “the manufacturing techniques lag far behind those of potato-chip and laundry-soap makers.” In short, your soap is manufactured in a more sanitary, industry standard compliant manner that your medication. So, are the futuristic drugs you’re getting really good for you?
Starting a Change
Since the article was published, the FDA has applied more stringent measures for the drug manufacturing process of the pharma industry. While many companies viewed this as another roadblock in their path to progress, the FDA has maintained that this is a necessity for the good of everyone involved. Industry standards must be met. It’s not an issue that the FDA takes lightly since in 2016, 2017 and 2018 the number of warnings for infractions issued for manufacturing has doubled.
With FDA enforcing high standards and the pharma industry slow to accept the change, there’s an odd market tension, particularly in cases where a drug recall has occurred. Over a period of 5 years, the number of drug recalls due to poor product quality has increased. This has created market shortages, and while this number had gone down from 251 to 35 by 2017, in January 2019, the FDA listed around 114 drugs that are currently experiencing a shortage and 207 drugs that have been discontinued.
Still More Room for Improvement
The good news here is that as there are more changes being introduced in the pharma industry, there is also room for improvement in the manufacturing area. Opportunities are also hinged on the adoption of newer technologies. These include 3D printing of various drug products, continuous manufacturing of certain solid dose drugs and more.
Additionally, the FDA is working hard to approve processes for continuousdrugmanufacturing. The support shown here has also sparked interest, and more companies are looking to make changes that allow them to cut down the process of not only manufacturing but also of drug delivery to the marketplace.
The good news here is that the issue has been recognized by the pharma industry and there are a lot of technologies available which can streamline this area. However, given the public attention on R&D, drug manufacturing is still an area that easily becomes overshadowed.