In a surprise move, U.S. President Barack Obama has signed into law a bill that extends the exclusivity time frame for new drugs, including those classed as biologics containing a controlled substance. Biologics are genetically-engineered proteins derived from human genes.
This protectionism has come about through the new Act altering the date by which medicines are considered to have been approved. This is change from when the current U.S. Food and Drug Administration (FDA) sign-off occurs to when the Drug Enforcement Agency (DEA) schedules the drug products for sale.
The bill is the “Improving Regulatory Transparency for New Medical Therapies Act,” Public Law 114-89. The law was passed after various concerns were voiced by pharmaceutical companies that can lose exclusivity rights in the time period while they are waiting for DEA action. If exclusivity rights are lost, then other pharmaceutical companies can make similar medications. In general this leads to greater competition and a lowering of the price of the medication.
A further change in the bill is that it will now be permissible to sell a controlled drug before the DEA assigns it to the schedule for controlled substances. This process, according to Pharmaceutical Processing, resets the date of approval. This requires the DEA to issue an interim final rule within 90 days following approval by the FDA. Now a medicinal product is able to be marketed while the final decision is pending.
In related pharmaceutical news, healthcare spending in the U.S. increased by 5.3 percent in 2014, according to newly released figures. This increase represents a $3 trillion total. The rise in spending by the U.S. healthcare system rose by the largest amount since 2007. Much of this increase relates to a big enrollment in private health plans, which increased by 2.2 million people to 189.9 million. In addition, some 7.7 million more people are covered by Medicaid, bringing the total under this scheme to 65.9 million.
