FDA Releases Proposal on Handling Drug Shortages
One of the major problems countries have with treating patients is getting enough medications at an affordable cost. The World Health Organization (WHO) recently reported on the issue with multi drug resistant tuberculosis in developing countries. These countries have better screening tests that end up diagnosing more people than the countries can care for, resulting in drug shortages. Drug shortages, however, do not only affect developing nations. This past Thursday, the U.S. Food and Drug Administration (FDA) revealed its proposal on handling shortages of vital medications in clinics and hospitals within the country.
"The FDA continues to take all steps it can within its authority, but the FDA alone cannot solve shortages. Success depends upon a commitment from all stakeholders," the agency's top drug regulator, Dr. Janet Woodcock stated according to USA Today.
In the proposal, the FDA stressed the importance of communication between the agency and drug manufacturing companies. The new rule requires companies that produce medically important prescription medicines to inform the FDA about any possible changes that could affect the supply of the drugs. Medically important prescription medicines are drugs that are "life supporting, life sustaining" or drugs that treat a "debilitating disease or condition." The proposal also requires companies that make non-drug biologic products, such as vaccines, to inform them of any changes as well. The companies must tell the agency six months before implementing any changes. These changes could include the discontinuation of a drug or manufacturing changes that could potentially slow down production.
The FDA hopes that when these companies report potential drug shortages within the near future, it would give the agency time to find alternative medicines for patients who might need them desperately. From 2011 to 2012, drug shortages fell from 251 to 117 due to earlier warnings. However, drug shortages overall have increased within the past six years. The FDA stressed that drug shortages are extremely detrimental for patients and could be the difference between life and death for some of them. Despite the threat of drug shortages, the FDA has announced that the penalty against companies that do not follow the new rule will be a "non-compliance" letter.
"We think that putting those up would emphasize the importance the FDA is placing on timely notification," Dr. Douglas Throckmorton, the FDA deputy director for regulatory programs, stated.
The FDA is currently taking comments regarding the proposal for up to 60 days. The FDA press release can be accessed here.