FDA has launched a pilot program to reassess the risks and benefits of typical NMEs 18 months after approval. CDER has selected
candidates from different new-drug review divisions and will be evaluating results in coming months. The aim is to identify
ways to detect safety concerns earlier in the review process, which could speed up approvals and reduce problems later.
Meanwhile, delays in launching new products are throwing monkey wrenches into manufacturers' business plans. Also, the emergence
of postmarket safety issues is proving disastrous for blockbuster products. FDAAA provides FDA with additional tools for assessing
product safety before and after approval, but the political rhetoric about manufacturer malfeasance is sure to continue in
this election year.
Scrutinizing imports
Drug-safety concerns, along with the crisis over contaminated food, pet food, and toys from China, has focused public attention
on how well FDA can detect and halt the import of dangerous products. The Bush administration issued an Import Action Safety
Plan in November, along with an FDA Food Protection Plan. Although the White House offered few new ideas and no specifics
about funding these proposals, the document is expected to spur action on Capitol Hill to revise how the government polices
imports. And while the focus has been on unsafe food products, the discussion has extended to the inspection and oversight
of drugs and drug substances that increasingly come from China, India, and other countries.
Questions about the quality of foreign drug products will prompt more Congressional scrutiny of drug and food imports in the
coming months. Legislators have cited FDA computer systems as inadequate for tracking foreign manufacturers and for the agency
to inspect foreign manufacturers in a timely and efficient manner. The Government Accountability Office reports wide disparities
in FDA estimates of the number of facilities exporting products to the US. This ambiguity adds to difficulties in developing
new solutions. Foreign drug inspections have long been compromised by a lack of funding and resources, by language barriers,
and by the need to announce site visits in advance. Most foreign plant audits involve preapproval inspections related to pending
new-drug applications, and few ensure compliance with good manufacturing practices.
Congressional leaders have proposed legislation to collect user fees on imports to support a more efficient inspection system
and to enhance FDA's authority to bar imports that lack appropriate production records. Some legislators want to form a single
food regulatory agency that would combine FDA, the US Department of Agriculture, and other federal operations. Policymakers
also seek more information about the scope of bulk-ingredient imports and the extent to which drug manufacturers conduct their
own inspections to ensure the quality of foreign products. FDA Commissioner Andrew von Eschenbach has proposed that FDA establish
satellite regulatory offices in China, India, and other countries as a way to improve the oversight of locally produced drugs.
Amid the outcry over inadequate foreign-drug oversight, FDA continues to struggle to meet requirements for inspecting drug
facilities in the US. The agency's field force has declined because of limited resources, and recent internal reorganization
plans have been derailed by opposition from agency staffers and Congress. Perhaps the focus on product safety will boost funding
for domestic regulatory activities as well as imports.
Examining drug prices
Despite concerns about poor-quality medical products from overseas, some members of Congress continue to press for more liberal
drug-reimporting policies to facilitate consumer access to low-cost medicines. The Medicare Part D drug benefit has significantly
increased government payments for drugs, thus intensifying public scrutiny of prices. High Medicare expenditures for anemia-fighting
erythropoietin, for example, sparked Congressional investigations and led to a curb on Medicare reimbursement for the drug.
And recent changes in the formula for Medicaid reimbursement for prescription drugs is prompting pharmacists to seek changes
in how the government calculates the average manufacturer price for medicines.
The desire to reduce the nation's prescription-drug bills also fits efforts to grant the government authority to negotiate
drug prices for Medicare Part D plans, curb drug advertising to reduce inappropriate prescribing, mandate disclosure of manufacturer
prices, and increase access to low-cost generic drugs. To further this last goal, Congress will continue to seek a pathway
for FDA to approve follow-on biologics. Congress decided to drop that issue from FDAAA, but generics makers have not let up
efforts to resolve the issue, and projections of big cost-savings from biosimilars are likely to keep it on the front burner
in the coming year.
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