Law.com Subscribers SAVE 30%
Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.
Drug Compounding: Many Considerations
The tug-of-war pitting patients against pharmaceutical companies against pharmacists selling competing compound drug mixtures to the public has lately gained greater urgency. Pharmaceuticals manufacturers contend that once their branded medications have been approved by the FDA, compounded concoctions that replicate them should not be permitted, as they are not subject to the same high safety standards and inspection requirements of the branded drugs. Consumers and pharmacists, among others, claim such arguments mask a different Big Pharma goal: the pursuit of high profits at the expense of patient access to affordable medications.
Now, a nationwide outbreak of fungal meningitis, likely caused by one component of a compounded drug, is altering the dialog. The suspect product in this instance is an injectable steroid, preservative-free methylprednisolone acetate (80mg/ml), which was produced by New England Compounding Center (NECC), in Framingham, MA. It was distributed across the country to pain clinics, which administered it to an estimated 13,000 patients. As of Oct. 9, 11 people who received these steroid injections had died of fungal meningitis, and 119 more had reportedly been sickened. Still more were anxiously waiting to see if they would develop symptoms of this non-contagious form of the disease.
This premium content is locked for Entertainment Law & Finance subscribers only
ENJOY UNLIMITED ACCESS TO THE SINGLE SOURCE OF OBJECTIVE LEGAL ANALYSIS, PRACTICAL INSIGHTS, AND NEWS IN ENTERTAINMENT LAW.
- Stay current on the latest information, rulings, regulations, and trends
- Includes practical, must-have information on copyrights, royalties, AI, and more
- Tap into expert guidance from top entertainment lawyers and experts
Already a have an account? Sign In Now Log In Now
For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473
Law Firms are Reducing Redundant Real Estate by Bringing Support Services Back to the Office
A trend analysis of the benefits and challenges of bringing back administrative, word processing and billing services to law offices.
New York's Latest Cybersecurity Commitment
On Aug. 9, 2023, Gov. Kathy Hochul introduced New York's inaugural comprehensive cybersecurity strategy. In sum, the plan aims to update government networks, bolster county-level digital defenses, and regulate critical infrastructure.
Bit Parts
Summary Judgment Denied Defendant in Declaratory Action by Producer of To Kill a Mockingbird Broadway Play Seeking Amateur Theatrical Rights
Risks of “Baseball Arbitration” in Resolving Real Estate Disputes
“Baseball arbitration” refers to the process used in Major League Baseball in which if an eligible player's representative and the club ownership cannot reach a compensation agreement through negotiation, each party enters a final submission and during a formal hearing each side — player and management — presents its case and then the designated panel of arbitrators chooses one of the salary bids with no other result being allowed. This method has become increasingly popular even beyond the sport of baseball.
Disconnect Between In-House and Outside Counsel
'Disconnect Between In-House and Outside Counsel is a continuation of the discussion of client expectations and the disconnect that often occurs. And although the outside attorneys should be pursuing how inside-counsel actually think, inside counsel should make an effort to impart this information without waiting to be asked.