As recalls mount for blood pressure drugs with potential cancer risks, a congressional committee wants the Food and Drug Administration to explain steps taken to contain the issue and, more broadly, to ensure that overseas manufacturers are not jeopardizing the U.S. pharmaceutical supply chain.
In a letter to the agency, the House Committee on Energy and Commerce expressed specific concerns about the ability to oversee foreign suppliers in the wake of an ongoing probe into a class of medicines known as angiotensin II receptor blockers, notably, valsartan.
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It is unrealistic to expect the FDA to inspect foreign manufacturing facilities. However, the FDA can determine whether a foreign regulatory authority is capable of performing its responsibilities. Congress should simply ban importation of drugs from foreign countries until the FDA certifies that the local regulatory authority can certify the quality of its products. Starting with China and India.
FDA has no tools to do that. It is part of the ANDA application. They can look at the records. They had the opportunity. Companies did not know or tell. FDA missed it till cancer was diagnosed.
Lawmakers asking FDA about the impurities is a good issue. Only choice FDA has is to ban the sale of the drug till the active ingredient producer and its formulator prove beyond shadow of doubt that there is no contamination. Other than that FDA has no authority.
FDA does not know how to fix the problem. They don’t have the expertise to examine the current process and know how the impurity is being produced. If they did this problem would have been solved. They also do not have the expertise to develop a new alternate process. Only conjecture is that recycling of solvent is potential cause.
May be FDA should re-examine the samples of Novartis’ Valsartan to see if the contaminant was there.
If solvent recycling and re-use is to stopped in pharma manufacturing because of this incident, law makers will make drugs expensive as most processes use solvent and that lower the cost. Non-recycle will mean used solvent has to be incinerated which means extremely high carbon dioxide emissions. Watch out Global Warming, you ain’t seen anything yet.