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The Food and Drug Administration is currently mulling the approval process for drugs that are similar to developed biologic drugs. However, the process is complex. Biologic drugs, unlike traditional chemical drugs — such as aspirin — are derived from living cells, which poses difficulties in replicating and reviewing an alternative version of the drug. The copy of the biologic drug is normally dubbed a ‘biosimilar’.
The drug manufacturer, Novartis AG, which may be the first firm to win U.S. approval of a copycat biotechnology drug, paid the RAND Corp. to look at potential domestic savings from the medicines. The RAND study, which was released on Monday, found that the introduction of biosimilar drugs would reduce direct spending on biologics in the U.S. by $44.2 billion from 2014 to 2024.
CQ HealthBeat’s (@CQHealthTweet) Kerry Young reported (subscription) on Monday that FDA is still reviewing comments on the biosimilar drug regulatory process. Separately, a guest opinion in Roll Call on Monday from Marcia Boyle, the chief of an immunodeficiency disease patient group, urged the FDA to carefully consider patient safety concerns since “even a minor difference between a biosimilar drug and the original biologic product, known as its innovator biologic, could have a significant adverse health impact for a patient.”
The Food and Drug Administration is ramping up requirements on medical device manufacturers to prove they have adequate cybersecurity protections. A growing number of medical devices are connected to hospital networks and the Internet or other devices, which makes them vulnerable to viruses or cyberattacks and the FDA has recorded an increase in incidence of device attacks over the past few years.
A 2012 federal auditor’s report commented on flaws in implantable defibrillators and insulin pumps and urged the agency to review device security requirements. The report prompted the FDA to begin developing regulatory guidance and the agency issued a 2013 safety alert on medical device communications security.
Today, FDA released final regulatory guidance to device manufactures on device functionality and safety when they connect to networks. The agency invites public comments on the recommendations to manufacturers when they seek to gain FDA approval of a medical device.
Vox.com pronounces that “The July effect is real: new doctors really do make hospitals more dangerous” in an article posted yesterday. As the site points out, the term “is shorthand for the supposed spike in medical mistakes at hospitals during the month of July — right when millions of medical residents start new jobs.”
Other publications have taken a crack at the topic in recent years; perhaps surprisingly, they’re not all from July. They sometimes cluster around a release of a study: