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Welcome to this month’s edition of Comp Medical News. Marijuana research, drug screening, and compounding rules are your headlines for August 2019.
Government Task Force Recommends Illicit Drug Screening for All Adults
The U.S. Preventive Services Task Force issued its determination that there is “moderate evidence” to screen for illicit drug use for all U.S. adults. The recommendation delineates that screening is not intended to diagnose the range of addiction and problematic use, but rather to indicate who could benefit from referral to services. The screening questions to not involve a drug test.
Read more here.
FDA Issues Statement on Compounding Bulk Substances
The FDA announced that a U.S. District Court judge in Washington, D.C. issued a decision that upheld FDA’s interpretation of clinical need regarding the bulk substances that may be used by outsourcing facilities in drug compounding. The decision was related to vasopressin, but has wider implications because it involves the agency’s method of defining what substances are available for compounders. The determination the FDA makes is whether there is a “clinical need” for the bulk drug substance, which is not the case if there is already an FDA-approved medication on the market to meet patients’ medical needs.
Read more here.
Big Pharma Making Generics to Eliminate Competition
Major pharmaceutical companies are creating their own generics at prices lower than standard generic makers, which could further accelerate the price of medication. According to a Kaiser Health News report, the phenomenon is called “authorized generics” and they can be more profitable than the blockbuster drugs they replicate. One example KHN found was for a blood pressure medication which goes for $208 per month for the brand name, the competing generic for $166 and the brand’s own generic for $187.
Read more here.
Louisiana Takes Aim at Kratom
The Louisiana Department of Health took aim at kratom, the herbal supplement that some people use as an alternative to painkillers, in a bill Governor Edwards signed into law back in June. The new law would ban kratom in Louisiana if the DEA classifies the substance as a Schedule I drug. That would place it in the same category as heroin. Kratom has caused a stir over the last several years because it can cause organ damage and other problems in very high doses.
Read more from the Gambit here.
States Ask Congress to Remove Opioid Treatment Barriers
A group of 38 states sent a letter to Congress earlier this month asking them to change federal laws that limit what doctors can do to address opioid use disorder. According to Property Casualty 360, the letter asks for three main adjustments:
- Replace medical privacy rules with those contained in the HIPAA statute.
- Increase access to buprenorphine, a major component of Medication Assisted Treatment, by passing HR 2452, the Mainstreaming Addiction Treatment Act.
- Repeal laws that prevent Medicaid from paying for certain types of addiction treatments.
Read more here.
DEA to Expand Marijuana Research
The DEA will again begin researching marijuana’s therapeutic qualities. The regulatory filing indicates that the DEA will soon provide guidelines for marijuana growers to produce their productions for medical research. Reuters says in its coverage that the move could indicate that the Trump administration is less interested in opposing marijuana now that many states have legalized it for either medical or recreational use.
Read more here
Politico: Government Officials Wanted to Warn Public about Opioids in 2006 But Effort Evaporated
A document obtained by Politico reveals that the Surgeon General wanted to warn Americans of the potential for the opioid crisis back in 2006 when opioids were flooding the market, but action was never taken. From Politico:
“The scientists’ March 15, 2006 memo, obtained under the Freedom of Information Act, shows that the directors from the National Institute on Drug Abuse and the National Institutes of Health flagged “disturbing” data showing a dramatic uptick in opioid addiction — including among teenagers — and requested urgent action. The agency directors wanted then-U.S. Surgeon General Richard Carmona to alert the public to the dangers of prescription drug abuse.”
Read more here.
Courtesy of Louisiana Comp Blog
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