Monday, August 29, 2011

There is a simple remedy to a serious problem

I quote from a statement by the U.S. Food and Drug Administration:
FDA recognizes the significant public health consequences that can result from drug shortages and takes tremendous efforts within its legal authority to address and prevent drug shortages. These shortages occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. FDA is aware that in 2010 there was a record number of shortages and in 2011 FDA has continued to see an increasing number of shortages, especially those involving older sterile injectable drugs.

When quality/manufacturing issues are discovered by the company or the public and reported to FDA or are found by FDA upon inspection, the FDA works closely with the firm to address  risks involved to prevent harm to patients.  FDA also considers the impact a shortage would have on patient care and access and works with the firm to restore supplies while also ensuring safety for patients.
We need legislation that will allow other firms to utilize produce patented drugs without license and to utilize patented processes to produce drugs without license when the patent holding firm can not meet the demand drugs for which there are no equivalent alternatives. In the face of shortages, the FDA should also be allowed to authorize the use of imported products on a temporary basis based only on their successful use in other nations with strong drug manufacturing regulation such as European nations, Japan and Canada.

I bet when firms find that failing to meet patient needs results in increased competition, they will suddenly find a way to meet those needs; if not, the alternatives will be there for the patients. If we have to balance the public good of providing life saving drugs to seriously ill patients or protecting patent rights of companies, the choice is clear!

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