in this issue
Are FDA Rules a Constraint to Innovation, Competition and a Cause of Bad Drugs?
3:50 PM MDT | October 6, 2010 | By GIRISH MALHOTRA
Rules are generally created to be followed. They maintain discipline. However, to innovate many times they are broken intentionally or unintentionally. Such forays lead to the creation of new rules. However, if the rules to be followed are cumbersome or become cumbersome, they can be a deterrent to innovation and competition. Companies need to maintain profitability while following complex rules that are difficult to comply with could ship marginally unacceptable product to the market. Such a practice would be violation of the public trust.
A review of the proposed US FDA process validation guidelines entitled “Process Validation: General Principles and Practices” suggest that the rules are complex. They instead will add complexity to the business operations, instead of simplifying manufacturing. At times, I wonder whether anyone has done a dry run and economic value analysis of the proposed or even of the adopted rules on any commercial process. The proposed rules will drive manufacturing by “regulatory centricity” rather than “product centricity," where the latter is really needed. It may well take an army of technocrats time to prepare, fill out and comply with the regulatory paperwork.
Simply said, the rules dictate how every step of the process needs to be documented rather than assisting in creating a simple, safe and sustainable process that will result in a repeatable, quality product. This is far less efficient than simply having a good process from the start, free of proscribed rules.
“Section III: Statutory and Regulatory Requirements For Process Validation” of the proposed process validation rules got my attention. It states the following:
“Process validation for drugs (finished pharmaceuticals and components) is a legally enforceable requirement under section 501(a)(2)(B) of the Act, which states the following:
A drug . . . shall be deemed to be adulterated . . . if . . . the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess.”
If the federal Food, Drug, and Cosmetic Act gives the US federal government an enforceable legal option, then why is the government not enforcing its legal obligation when it comes to drugs that do not comply with specifications or are contaminated with foreign substances?
Marketing and formulation companies through their alliance market a product that meets specification and has to be produced following the rules. In recent years we have seen increasing amounts of unacceptable product in the market. It could be due to increased outsourcing and companies unable or unwilling to follow complicated rules. If a product that does not meet the specifications shows up in the public domain it is violation of the company’s committed public obligation and trust. A question needs to be asked: “Why are companies failing in their public commitment?”
Governments have allowed recalls of bad product hiccups. If a commercialized material does not meet agreed specifications, could the distribution of “off-spec” products by pharmaceutical companies be considered criminal offense, as they have failed to adhere to the established standards? Could the complexity of rules that outline the how, what and why of manufacturing allow some of the product to slip through the quality checks in place? Could the rules act as a deterrent to competition and also prevent innovation in pharmaceutical manufacturing processes?
Our objective should be to simplify the rules and the processes, so they can foster innovation and competition through manufacturing simplicity and produce a consistent quality product all the time.