CONGRESSWOMAN ELISE STEFANIK
On Wednesday, June 20, 2012, the House is scheduled to consider a House Amendment to S. 3187, the Food and Drug Administration Safety and Innovation Act of 2012, under a suspension of the rules, requiring a two-thirds majority for approval. S. 3187 was introduced by Sen. Tom Harkin (D-IA) on May 15, 2012 and was passed in the Senate by a vote of 96-1 on May 24, 2012. The House approved a version of FDA Reform in H.R. 5651 on May 30, 2012, by a vote of 387-5.
The House amendment to S. 3187 would modify how the Food and Drug Administration (FDA) regulates drugs and medical devices in a range of areas. Principally the bill would reauthorize two existing user-fee drug and medical device review programs scheduled to expire on September 30, 2012, and would create two new user-fee drug review programs. Other reforms include the establishment of a new fee program related to rare pediatric diseases, the permanent reauthorization of FDA programs that evaluate the use of drugs by children, as well as other non-fee related activities to modify how the FDA regulates drugs and devices. The bill would also provide the FDA with additional regulatory authority to address the safety of the nation’s drug supply chain as well as systems to prevent future drug shortages.
Medical Device Regulatory Reforms
The bill would permit the Secretary of Health and Human Services (HHS), with responsibility delegated to the FDA Commissioner, to change the classification of a medical device by administrative action. The process would require the FDA to convene an advisory panel to recommend or not recommend the classification change. Under current law, the convening of an advisory panel is discretionary.
The bill would also require the Secretary to issue proposed regulations which establish a unique medical device identification system by December 31, 2012, which takes into account patient safety and access to medical devices and therapies. The 2007 FDA Reauthorization established this identification requirement upon the FDA, but the FDA has not yet promulgated these regulations.
Drug Supply Chain Reforms
The bill would expand the required product listing information that drug manufacturers must illustrate in their annual FDA notifications to include drug excipients (drug excipient are non-active ingredients)
The bill would also permit the FDA to share certain confidential drug information with trusted foreign countries. A provision in H.R. 5651 permitted the FDA to share information with foreign state and local governments.
Additionally, the bill would permit the FDA to take into account the drug facility inspections of domestic drug facilities by trusted foreign governments. Under current law, the FDA is required to inspect domestic drug facilities every two years. This provision would allow the FDA to rely on the inspections of these domestic facilities by trusted foreign governments in determining whether to inspect certain domestic drug facilities.
The bill would also increase the federal penalties and prison times and fines (or both) for persons who knowingly and intentionally commit acts related to trafficking in counterfeit drugs. This provision is similar to the provisions adopted in H.R. 3668, which passed the House by voice vote on Monday, June 18, 2012.
The bill would provide an additional five years of market exclusivity to manufacturers that develop new qualified infectious disease products (QIDPs). QIDPs would be defined as antibacterial or antifungal drugs intended to treat serious or life-threatening infections. A comparable provision in H.R. 5651 required a manufacturer to prove that the new antibiotic had an impact that cured a specific pathogen. The new provision would require only that the manufacturer show that the antibiotic treats a serious or life-threatening infection.
Drug Approval and Patient Access
The bill would require the development of best practices to assist the visually-impaired or blind obtain prescription drug label information as well as a Government Accountability Office (GAO) study on utilization of such best practices.
The bill would also require the Secretary to publish on the FDA’s website a report examining the extent that clinical trial participation and the inclusion of safety and effectiveness data by demographic subgroups (including sex, age, race, and ethnicity), are included in applications submitted to the FDA.
The bill would modify existing FDA reporting requirements for drug manufacturers who produce drugs that are life-supporting, life-sustaining, used to prevent or treat debilitating diseases or conditions, as well as drugs used in emergency medical care or surgery. The bill would also authorize the Secretary to expedite drug establishment inspections for supplements and drug applications that could help mitigate or prevent a drug shortage. This section does not apply to biologics. However, the Secretary has the regulatory authority to promulgate regulations that include biologics in this reporting requirement.
The bill would also require the Secretary to create a task force to enhance the Secretary’s response to shortages, and create a strategic plan to address stated aspects of shortages.
The bill would require the FDA to either accept foreign clinical data or notify the drug or device applicant of the FDA’s rationale for its decision that the data are not adequate to support approval, licensure, or clearance under applicable FDA standards.
The bill would also require the GAO to examine problems posed by online pharmacy websites that violate state or federal law.
Further, the bill would extend the tentative approval time period of generic drug applications for those generic drug manufacturers who challenge a brand manufacturer’s patent as being invalid from current law 30 months to 40 months (with a gradual phase down back to the 30 months while the FDA eliminates the backlog of pending generic applications). According to the House Energy and Commerce Committee, the FDA average response time for tentative generic approvals is 32 months. (H.R. 5651 included a 45 month extension.) Upon tentative approval of such generic applications, these applications receive 180 days market exclusivity vis-à-vis other generic competition.
The bill would also require the FDA to take a final agency action on certain citizen petitions regarding generic drug and biosimilar applications within 150 days. These petitions request the FDA to delay approval of generic applications based on scientific or medical questions. The FDA is required under current law to take final agency action on these petitions with regard to generic drugs within 180 days.
The bill would require the FDA to hold public meetings on the scheduling of hydrocodone. (Senate efforts had attempted to classify hydrocodone as a Schedule II drug, which has a high potential for abuse that may lead to severe psychological or physical dependence.)
Lastly, the bill would amend the Controlled Substances Act to designate certain synthetic substances as Schedule I drugs, which are drugs that have a high potential for abuse, have no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use of the drug or other substance under medical supervision. This provision is similar to the House-passed H.R. 1254 that passed the House by a vote of 317-98.
The United States has led the global medical device and biopharmaceutical industries for decades. This leadership has made the U.S. the medical innovation capital of the world, bringing hundreds of thousands of high-paying jobs to our country and lifesaving devices and drugs to our nation’s patients.
The significant policy reforms contained in this legislation, along with the additional resources and
accountability measures in the user fee agreements, would address the regulatory uncertainty at FDA so the U.S. would remain the world leader in medical innovation, device and drug jobs would remain in the U.S., and U.S patients would continue to benefit from new devices and drugs, without compromising FDA’s appropriately stringent standards that protect patients from unsafe or ineffective devices and drugs.
The new generic drug user fee would provide additional resources for the review and regulation of generic drugs. These resources would bring faster and more predictable review of generic drug applications and increased inspections of generic drug facilities, bringing parity to the frequency of inspections of foreign and domestic generic drug facilities. Reducing the amount of time the FDA is required to take action would have the effect of reducing federal spending on medications provided for in Medicare, Medicaid, and other federal health programs because less expensive generic drugs (and now biosimilars) could reach the market sooner. Similarly, the new biosimilar user fee would provide additional resources to FDA for the review of biosimilar applications.
This bill would take important steps to address the current drug shortage crisis affecting the U.S.
According to CBO, the bill as amended would result in a reduction in the deficit of $113 million over the 2012-2017 period, which is the sum of a reduction in direct spending of $112 million and an increase in revenues of $1 million. Similarly, the 10-year net reduction in deficits of $311 million is the sum of a reduction in direct spending of $307 million and an increase in revenues of $4 million.