Regulatory Roundup
Budget battles
In addition to relying on ever-greater user fees to finance FDA operations ($2 billion in fees on a $4.5-billion budget),
the Obama administration's spending plan for fiscal year 2013 takes some heavy swipes at biopharmaceutical companies. The
president proposes to lower the exclusivity period for innovator biologics to seven years from 12 and to ban brand-generic
"pay-for-delay" settlements. There's also the Democratic favorite to extend Medicaid rebates to all low-income beneficiaries
in Medicare Part D plans, which is calculated to cut spending by $156 billion over 10 years. John Castellani, president of
the Pharmaceutical Research and Manufacturers of America (PhRMA), blasted these proposals in a statement as a counter to "Obama's
many pronouncements to support innovation, advance biomedical research, promote job creation and control healthcare costs
for seniors." Congressional Republicans rejected the Obama budget immediately, taking particular aim at the administration's
request for another billion dollars to fund healthcare reform, along with the antipharmaceutical provisions.
Chinese suppliers
US regulators have expanded the so-called "import alert" list to include 14 more Chinese producers of heparin and related
products, for a total of 22 Chinese firms linked to the heparin contamination crisis of 2008 and still unable to meet FDA
standards for manufacturing and quality control. The move additionally aims to assure Congressional Republicans that FDA is
serious about ensuring the safety of heparin products in the US.
FDA also aims to bolster its presence in China by seeking an additional $10 million in its FY 2013 budget to expand the scope
of in-country inspections and staff. A new FDA report to Congress on its foreign offices and operations, as required by recent
food-safety legislation, summarizes FDA overseas activities and interactions with regulatory authorities in China, India,
Latin America, Europe, Africa and the Middle East, designed to build rapport and obtain important information on local production
and regulatory operations.
Foreign corruption
Manufacturers are supporting a new mandatory code of conduct for dealing with doctors and other providers around the world,
largely to offset charges of violating the US Foreign Corrupt Practices Act (FCPA) and similar laws set by other countries.
Spurred by a rise in investigations and charges levied against pharma companies by US and foreign enforcement agencies, the
International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has updated its ethical practice code to
cover broader industry interactions with health professionals. Astra Zeneca CEO David Brennan, IFPMA president, said in a
Mar. 1, 2012 statement, that the new policy can help industry "act with integrity and build trust." The code bans gifts and
curtails entertainment to docs—and may save manufacturers in legal fees and fines: Johnson & Johnson paid some $70 million
last year to settle charges of illegal payments overseas, and Serbia is investigating several bio/pharmaceutical companies
for bribery and corruption.
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