Today, Senator Richard Blumenthal (D-CT) hailed the passage of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA). FDASIA passed the Senate by a vote of 92-4 and will be sent to President Obama to be signed into law. The bill passed the House last week by a majority voice vote.
In general, FDASIA will help speed the delivery of safe and effective drugs and medical devices. Blumenthal championed thirteen of the provisions included in the bill -- provisions that improve federal policy related to antibiotic development, drug shortages, medical devices, medical gases, and synthetic drugs.
"Superbugs or antibiotic resistant infections like MRSA or E. coli are a nightmarish threat and that is why I spearheaded a law to spur the invention of new antibiotics to treat them," Blumenthal said.
Blumenthal added, "Also, in the greatest nation on earth with the best medicines known to man, there is no excuse for shortages of life-saving, cancer-fighting drugs or drugs essential for emergency anesthesiology -- and that is why I championed measures to prevent such drug shortages. I listened to people in Connecticut who are victims of these problems, and helped forge bipartisan coalitions in the Senate to fight them."
He continued, "Finally, fatalities and horrible injuries resulting from bath salts and other synthetic drugs led me to advocate for measures to combat them as well."
Blumenthal introduced or helped lead the following provisions 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.
* Public-private partnership to address manufacturing deficiencies: The measure passed today includes a provision based on an amendment that Blumenthal offered during the Senate floor debate that requires the FDA to examine the establishments and incentives needed to create partnerships with qualified manufacturers to rapidly increase manufacturing of drugs at risk for shortage. Drugs in shortage are most often those with long-term limited manufacturing capacity; this provision will help ensure that FDA considers the full range of solutions to ensure that back-up capacity to produce more of the drugs that are needed is always available.
* 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 a 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 to effectively identify when unsafe medical devices were on the market. Blumenthal introduced legislation to require FDA to assess its recalls, and implement an electronic system that can identify trends in unsafe devices on a real-time basis to prevent potential issues before they happen.
* Enhancement of post-market surveillance tools: Currently, the FDA can only require post-market surveillance on 510(k) pathway medical 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 medical 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 consumers. Blumenthal created a mechanism in the FDSIA for FDA to approve medical gases before they come to the market.
* Classifies "bath salts" as Schedule I Controlled Substances: Schedule I Controlled Substances are considered to have a high potential for abuse, and have no legitimate medical purpose. Despite this, commonly abused drugs known as "bath salts," which cause effects such as hallucinations and suicidal thoughts, and are not accepted for use in medical treatment, have not been permanently listed as Schedule I Controlled Substances. These drugs are not designed to dissolve in the bath, but are instead highly addictive synthetic stimulants, and are sold illegally in convenience stores and smoke shops. This provision permanently classifies synthetic substances as Schedule I Controlled Substances, making it is illegal to prescribe, administer, or dispense them.
* Classifies synthetic marijuana as a Schedule I Controlled Substance: Synthetic marijuana is a commonly abused substance that is manufactured in a lab; it is frequently laced with harmful chemicals, causes intense hallucinations, and is not accepted for use in medical treatment. A few types of synthetic marijuana have been temporarily listed as one of the Department of Justice's Schedule I Controlled Substances -- substances which are considered to have a high potential for abuse, and have no legitimate medical purpose. This provision permanently classifies all types of synthetic marijuana as a Schedule I Controlled Substance, making it illegal to prescribe, administer, or dispense it.
* Classifies "2C substances" as Schedule I Controlled Substances: "2C substances," which cause stimulant and hallucinogenic effects similar to LSD, have caused at least three deaths in the last year. These substances are frequently abused and have no legitimate medical purpose, but are still not listed as Schedule I Controlled Substances -- substances which are considered to have a high potential for abuse, and are not accepted for use in medical treatment. This provision categorizes "2C substances" as Schedule I Controlled Substances, making it is illegal to prescribe, administer, or dispense them.