Manufacturers generally support stronger early notification requirements, largely to counter charges about low-quality production,
and decisions to drop a critical drug that puts profits over patients. In addition to early warnings about supply problems,
FDA wants industry to identify and promptly correct manufacturing violations and to implement quality-by-design strategies
to prevent production failures in the future. Manufacturers can head off shortages, say FDA officials, by developing continuity
of supply plans, with backup suppliers and alternative production strategies that achieve redundancy in production for key
therapies. On their part, manufacturers want the Drug Enforcement Agency (DEA) to be more flexible in increasing annual quotas
on active ingredients for controlled substances when a competitor halts production.
Industry also hopes that better compliance will head off more onerous regulation. Critics are urging antitrust officials to
scrutinize proposed pharma company mergers more closely to assess whether a new combination would jeopardize future drug supplies.
Some providers want the federal government to establish stockpiles for medically necessary drugs, as is done for treatments
against bioterrorist attacks and pandemics. There's also broad support for FDA to have more resources to expand its very small
drug shortage program, which was established in 1999 to manage anticipated supply disruptions with the Y2K shift to the new
Along with stiffer rules and penalties, there's interest in offering added incentives for manufacturers to enter depleted
markets. These include tax credits or rebates for manufacturers that update facilities or launch production of low-profit
drugs. Some kind of exclusivity could be provided for new production of drugs in short supply or identified as vulnerable
to supply problems. Or, generic drug makers might be eligible for reduced user fees on applications to revise or expand production
of hard-to-obtain medicines.
Parallel to the shortage crisis, FDA has been campaigning for more authority to control drug counterfeiters and manage an
increasingly global pharma supply chain. A number of bills before Congress would strengthen FDA's ability to halt illegal
imports and to ensure quality pharmaceutical production at home and abroad.
At a hearing Sept. 14 before the Senate Health, Education, Labor, and Pensions (HELP) Committee, Deborah Autor, recently named
FDA deputy commissioner for global regulatory operations and policy, presented a long wish list of policy changes that would
promote drug safety and level the playing field between domestic and foreign manufacturers. Autor wants mandatory recall authority
for drugs, power to detain and destroy violative imports at the border, and much stiffer penalties for noncompliance. Drug
manufacturers and importers would have to register and list manufacturing facilities using identifier numbers, and importers
would have to demonstrate that they meet quality standards, instead of FDA having to prove that they do not. Autor also seeks
to establish a stronger track-and-trace system, which would help hospitals and physicians know whether drugs from unknown
sources are legitimate. And foreign companies that refuse FDA inspections could not export to the US.
Industry supports many of these changes, but is wary that overly strict requirements could make low-profit markets less attractive
to manufacturers. The challenge is to strengthen FDA without creating more shortages.
Yet, patients are waiting. Short supplies of drugs to treat children with leukemia is "shameful," lamented oncologist Len
Lichtenfield at the FDA workshop. "It's hard to believe that in this country, because a drug doesn't make a lot of money,
we can't provide necessary drugs and parenterals."
Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at email@example.com