After Heparin: - The Pew Charitable Trusts

BARRIERS TO FDA OVERSIGHT
2.2.2 Over-the-counter products receive less scrutiny
Plants making OTC medications or active ingredients receive less FDA scrutiny than those making prescription
drugs, particularly when those plants are overseas. There are at least two reasons: first, the vast
majority of the FDA’s foreign inspections are pre-approval inspections, 374 which do not apply for most
OTC products. * Ibuprofen, acetaminophen and acetylsalicylic acid (aspirin)—three active ingredients for
which the majority of U.S. imports originated in China in 2009—are among the OTC products in this
category (see figure 9). Secondly, the FDA considers OTC products to be lower risk than prescription
products within the agency’s risk-ranking model for plant oversight. 375 Despite this oversight disparity,
numerous experts interviewed for this paper assert that the risks of GMP failures for OTC products are
not intrinsically lower than for prescription products. 376–379 Indeed, an auditor of Chinese manufacturing
facilities considers the lack of oversight of the OTC sector to be a major problem, because large product
volumes make it easy for suppliers to covertly introduce cheaper materials not certified for pharmaceutical
use. 380 While the United States rarely inspects overseas OTC plants, the E.U. authorities conduct
more frequent OTC inspections. This oversight has sometimes identified quality issues that resulted in a
suspension or withdrawal of approval to produce for E.U. markets.
2.3 FDA capacity and information systems
2.3.1 FDA’s inspection staff
The FDA Office of Regulatory Affairs (ORA) is responsible for all agency regulatory activities, including
oversight of drug and device manufacturing through physical inspection of plants and products in the
United States, outside of the United States and at import. Despite industry globalization trends, ORA
personnel and financial resources remain largely focused on domestic oversight. Until fiscal year 2009,
the FDA did not have dedicated staff for foreign inspections; qualified employees would volunteer to
travel abroad. The FDA estimated in 2007 that approximately 335 ORA employees were qualified to
conduct foreign inspections, although only 102 did so in the year prior. 381 In fiscal year 2009, the FDA
created a “cadre” of 15 inspectors dedicated to inspecting foreign manufacturing sites. These inspectors
were based in the United States and performed about a third of all the FDA’s foreign inspections in that
year. 382 However, the GAO notes that these staffing increases have not yet resulted in sufficient levels of
foreign oversight. 383 The FDA committed a major part of its increased 2009 appropriations to hiring new
staff, with a primary goal of bolstering ORA’s inspectorate. However, hiring and retaining employees has
been historically difficult, in part because of competition from the higher-paying private sector. 384
To improve its overseas presence, the FDA has opened offices in key geographic regions: three in China,
two in India and three in Latin America, with planned offices in the Middle East and Europe. 385 These
* OTC medications fall into two categories: (1) those approved under a drug marketing application, and (2) those that comply with an existing OTC
monograph. Manufacturers of OTCs in this second category are not required to submit pre-market applications to the FDA that describe manufacturing
processes and sites. These products may be marketed without specific FDA approval and are therefore not subject to pre-approval inspection.
After Heparin: PRotecting Consumers from the Risks of Substandard and Counterfeit Drugs 49