By Bronwyn Mixter
President Obama July 9 signed into law the Food and Drug Administration user
(S. 3187, Pub. L. No. 112-144).
The law reauthorizes the user fees paid by medical device and drug companies:
device companies are expected to pay $595 million over five years (fiscal years
2013 through 2017), while drug companies will pay $693 million in the first
year. The new law also creates user fee programs for generic drugs and
biosimilar (or follow-on biologic) drugs. The user fees supplement congressional
appropriations for FDA.
In addition to the fees, the Food and Drug Administration Safety and
Innovation Act includes numerous regulatory provisions affecting drugs and
devices, such as incentives for the development of antibiotics, provisions to
prevent drug shortages, and a requirement that FDA issue guidance on use of the
internet and social media to promote FDA-regulated medical products.
The Senate approved the bill June 26, in a 92-4 vote. The House approved the
bill June 20 unanimously (6 MELR 413, 6/27/12).
“This legislation, which passed both the House and Senate with overwhelming
bipartisan majorities, will help speed safe and effective medical products to
patients and maintain our Nation's role as a leader in biomedical innovation,”
Kathleen Sebelius, secretary of the Department of Health and Human Services,
said in a statement.
The bill “is the culmination of the work of the administration and Congress,
in partnership with patients, the pharmaceutical and medical device industries,
the clinical community, and other stakeholders, to provide [FDA] with the tools
needed to continue to bring drugs and devices to market safely and quickly and
promote innovation in the biomedical industry, and to help secure the jobs
supported by drug and device development,” Sebelius said.
Sebelius said the bill will accelerate approval of lower-cost generic drugs
and fund the new approval pathway for biosimilars. “These new programs are
important to increasing patient access to affordable medicines,” she said.
Additionally, Sebelius said the legislation “enhances the tools available to
the FDA to combat drug shortages by requiring manufacturers of certain drugs to
notify the FDA when they experience circumstances that could lead to a potential
“Provisions in the legislation also will help enhance the safety of the drug
supply chain in an increasingly globalized market, increase incentives for the
development of new antibiotics, renew mechanisms to ensure that children's
medicines are appropriately tested and labeled, and expedite the development and
review of certain drugs for the treatment of serious or life-threatening
diseases and conditions,” Sebelius said.
When the Senate passed the user fees bill, attorney John Manthei, with Latham
& Watkins LLP in Washington, said in a statement that “although some of the
more controversial provisions were taken out of the bill during the final
deliberations, the reforms that made it into the law will hopefully result in a
more timely, transparent, and predictable FDA.”
Manthei noted that with all the additional funding, “FDA is going to have a
hard time arguing that it does not have sufficient resources to accomplish its
The newly signed Food and Drug Administration Safety and Innovation Act
includes “medical device regulatory improvements” in Title VI of the law.
Key device-related provisions include:
clarification of the least burdensome standard for applications (Section 602 of
requirement that FDA reports to Congress on when sponsors should submit a 510(k)
due to the modification of a device already cleared for marketing (Section
of a system to assess device recall information (Section 605);
of the de novo application process, which allows a company to request
classification of a device instead of having to submit a 510(k) (Section
FDA to change the classification of a device based on new information (Section
with other nations to harmonize regulatory requirements (Section 609);
of the post-market Sentinel safety analysis system by adding devices to the
database (Section 615); and
of a strategy for regulating health information technology, including mobile
medical applications (Section 618).
Allan Coukell, director of medical programs at the Pew Health Group, said in
a statement that by signing the bill, “President Obama has ensured that the FDA
will have the resources and authority it needs to promote the development of
safe, effective and innovative medical products that Americans need.”
“This Administration should recognize the broad, bipartisan support this bill
has earned and implement it without delay,” Coukell said.
The Medical Imaging & Technology Alliance (MITA) applauded President
Obama for signing the bill into law.
“We commend the President and the bipartisan efforts of Congress to enact
this legislation, which is an important step toward maintaining a transparent
and efficient FDA review process that will foster the development of innovative
technologies,” Gail Rodriguez, executive director of MITA, said. “MITA and its
industry partners worked closely with the FDA and Congress to develop a user fee
agreement that improves the pre-market review process, while safeguarding
patient access to safe and effective medical imaging and radiation therapy
technologies. We look forward to working closely with the FDA as the law is
implemented to ensure patients benefit from this important legislation.”
Rich Umbdenstock, president and chief executive officer of the American
Hospital Association, said in a July 9 statement that his group thanks the
president for signing the law. “The number of drug shortages has tripled in the
last six years and they are having an impact on patient care. However, the new
law is a concrete step in the right direction in addressing this issue.”
The AHA leader said that, with nearly 100 percent of hospitals reporting
shortages, “access to life-saving drugs is essential. The law will help
hospitals obtain that critical access.” He said the new law helps ease the
strain that hospitals across the country have faced in dealing with drug
shortages by improving communications between manufacturers and the public, by
giving FDA additional authority to speed up approvals, and by allowing health
systems “to take practical steps to conserve their inventory of drugs.”
When the Senate passed the legislation, the Application Developers Alliance
June 26 issued a statement applauding Congress for passing the bill and for
directing the Office of the National Coordinator for Health Information
Technology, the Federal Communications Commission, and FDA to ensure that
government regulation of medical mobile applications “promotes innovation,
protects patient safety, and avoids regulatory duplication.”
The bill directs the three agencies to produce a report on an appropriate
regulatory framework for health information technology, including mobile medical
applications. Under the bill, the Department of Health and Human Services may
convene a working group of outside stakeholders to help develop the report.
The Application Developers Alliance urged FDA to quickly convene the working
group. The working group should ensure that the three agencies have access to
application developer expertise when developing their strategic plan, the
alliance said. The Application Developers Alliance is a new association
dedicated to meeting the unique needs of application developers. Alliance
members include more than 7,500 individual application developers and more than
80 companies, investors, and stakeholders.
The bill is at http://republicans.energycommerce.house.gov/Media/file/PDFs/BILLS-112s3187-SUS.pdf.