FDA seeks advance drug shortage alerts
WASHINGTON — The Food and Drug Administration announced a new proposal on Thursday to try heading off more shortages of crucial medications that have disrupted care at hospitals and clinics nationwide.
Under the proposed rule, companies that make medically important prescription medicines would have to notify the FDA six months before any changes that could disrupt the supply. The rule would include plans to discontinue a product or any manufacturing changes that could slow production.
“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,” said Dr. Janet Woodcock, FDA's top drug regulator, in a statement.
Agency leaders say advance warnings help the agency work with companies to resolve supply problems or find alternate producers for drugs that are being phased out. The FDA credits earlier warnings from companies with reducing the number of drug shortages from 251 in 2011 to 117 last year.
Drug shortages have increased during the past six years, particularly those involving inexpensive generic injected drugs — powerful antibiotics, painkillers and anesthetics used in surgery. The drugs are the workhorses of hospitals but are difficult to make and produce little profit for drugmakers.
Some cancer drugs have been in short supply, disrupting treatments that require medication administered on a precise schedule.
The FDA proposal expands and strengthens existing requirements passed by Congress last year and an executive order issued by President Obama in 2011. The measures require pharmaceuticals that are the sole manufacturer of a drug to contact the agency ahead of any supply disruptions. The new proposal would expand the requirement to any company making a drug that is “life-supporting, life-sustaining” or used to treat a “debilitating disease or condition.” The FDA plan would expand the requirement to non-drug biologic products, such as vaccines.
Penalties against companies that don't comply would not be very severe. FDA officials said the agency will post on its website “non-compliance” letters to companies that fail to provide enough advance notice.
Show commenting policy
TribLive commenting policy
You are solely responsible for your comments and by using TribLive.com you agree to our Terms of Service.
We moderate comments. Our goal is to provide substantive commentary for a general readership. By screening submissions, we provide a space where readers can share intelligent and informed commentary that enhances the quality of our news and information.
While most comments will be posted if they are on-topic and not abusive, moderating decisions are subjective. We will make them as carefully and consistently as we can. Because of the volume of reader comments, we cannot review individual moderation decisions with readers.
We value thoughtful comments representing a range of views that make their point quickly and politely. We make an effort to protect discussions from repeated comments either by the same reader or different readers.
We follow the same standards for taste as the daily newspaper. A few things we won't tolerate: personal attacks, obscenity, vulgarity, profanity (including expletives and letters followed by dashes), commercial promotion, impersonations, incoherence, proselytizing and SHOUTING. Don't include URLs to Web sites.
We do not edit comments. They are either approved or deleted. We reserve the right to edit a comment that is quoted or excerpted in an article. In this case, we may fix spelling and punctuation.
We welcome strong opinions and criticism of our work, but we don't want comments to become bogged down with discussions of our policies and we will moderate accordingly.
We appreciate it when readers and people quoted in articles or blog posts point out errors of fact or emphasis and will investigate all assertions. But these suggestions should be sent via e-mail. To avoid distracting other readers, we won't publish comments that suggest a correction. Instead, corrections will be made in a blog post or in an article.
- The ‘McQueen effect’: A car owned by late actor can fetch 3 to 5 times its worth
- White House ricochets in nonprofits’ birth control coverage fray
- His murder-arson conviction overturned, man walks free 24 years later
- NASA expected to hire private rocket
- U.S. could have done better, says brother of slain journalist
- Obama pressured to obliterate ISIS as attack risks rise
- Reid apologizes for jokes at Asian business event
- Hackers hit 25,000 government workers
- Retailers warned about software
- Mudslides plague Washington state after wildfire strips hillsides
- Rehabilitated snowy owl dies in Minnesota