(Washington, DC) – Today, the United States Senate passed the FDA Safety and Innovation Act (FDASIA), landmark legislation that ensures the Food and Drug Administration (FDA) can approve prescription drugs, medical devices, and biosimilars quickly and effectively. Senator Richard Blumenthal (D-CT) championed a number of provisions that passed in this legislation, all of which will increase protections for consumers across the country.
“This measure renews the FDA’s ability to safeguard patients and drug safety, and also takes major steps to advance a dramatic expansion of FDA’s authority to prevent drug shortages and fight antibiotic resistant germs. I championed these proposals because of the threats to health posed by drastic drug shortages of workhorse medicines and anesthetics at hospitals and doctors’ offices, and the nightmarish threat posed by so-called ‘superbugs.’ Senate passage today exemplifies the progress we can make on key issues when working in a bipartisan fashion,” said Blumenthal.
Blumenthal introduced or helped lead the following nine priorities in FDASIA:
• Incentivizing the development of new antibiotics: While bacterial infections continue to become more resistant to traditional antibiotics, innovation of new antibiotics capable of combating these infections has slowed by an alarming rate. Blumenthal was responsible for the addition of the Generating Antibiotic Incentives Now Act to FDSIA, including five years of FDA Data Exclusivity for companies that develop innovative drugs to treat serious and life-threatening “superbugs”, priority review and fast-tracking for applications at FDA, and additional guidance for effective clinical trials from FDA.
• Mandated reporting on drug shortages: Last year, the FDA reported 178 drugs in shortage; shortages cost the U.S. health care system over $200 million annually. Many of these shortages went unreported to the FDA for too long, leaving hospitals to frantically search for alternative treatments. Blumenthal championed a provision to require all manufacturers to notify FDA at least six months in advance of any discontinuation of life-supporting or life-sustaining drugs, or any drugs intended for use in the prevention of a debilitating disease or condition.
• Expedited inspections and review of applications: When a drug is in shortage, other manufacturers are prevented from quickly producing it because the FDA must first approve the new manufacturer’s drug and inspect the manufacturing site. Blumenthal’s provision will give the Secretary of Health and Human Services the authority to prioritize New Drug Applications and plant inspections for drugs that are in shortage, or are at risk for being in shortage in the future.
• Congressional reporting on market manipulation and drug pricing: Currently, information on market manipulation and drug pricing is unavailable to Congress. Blumenthal championed a provision to require the Department of Health and Human Services, in coordination with other federal agencies, to report to Congress any findings that drug shortages have led market participants to stockpile affected drugs or sell them at significantly increased prices.
• Distribution of information to health care providers: Today, health care providers are provided with little, if any, advance notice of discontinuance of certain drugs. Blumenthal’s provision directs the FDA to develop better disseminate information about drug shortages to providers on a real-time basis.
• Enhancing penalties for creating, selling, or dispensing counterfeit drugs: Counterfeit drugs are increasingly developed and sold by a number of parties throughout the country and abroad, posing extreme safety threats to consumers. Blumenthal supported provisions to enhance the penalty for those who create, sell, or dispense counterfeit drugs, increasing the penalty to maximum 20 years imprisonment or a maximum fine of $1 million.
Medical Device Safety
• Improved recall process: The Government Accountability Office found last year that the FDA was unable effectively identify when unsafe devices were on the market. Blumenthal introduced legislation to require FDA to assess its recalls, and implement an electronic system that and can identify trends in unsafe devices on a real-time basis to track potential medical device issues before they happen.
• Enhancement of post-market surveillance tools: Currently, the FDA can only require post-market surveillance on 510(k) pathway devices if there is a sign of safety concerns, or if the device is high-risk. As a result, FDA must wait for a sign of harm before requiring surveillance of a device. Blumenthal’s legislation clarifies existing language to explain that FDA has authority to require post-market surveillance in the 510(k) expedited device approval process.
Medical Gas Regulation
• Creation of an approval process for medical gases: Currently, medical gases, like Oxygen and Nitrous Oxide, are widely used, yet to date, no regulation or approval process exists at the FDA, creating uncertainty for manufacturers and for consumers. Blumenthal created a mechanism in the FDSIA for FDA to approve medical gases before they come to the market.