Congress Widens Drug Industry Probe
The chairman of a congressional committee that has been investigating corruption and fraud in the generic drug industry for the past year said Tuesday that the probe was expanding to the makers of brand-name products.
The first target of the expanded inquiry is to be Eli Lilly & Co. of Indianapolis, House Energy and Commerce Committee Chairman John Dingell (D-Mich.) disclosed in a letter to Food and Drug Administration Chief Frank E. Young.
The letter was made public late Tuesday.
Dingell’s letter was prompted by Lilly’s announcement earlier Tuesday that the drug maker had begun a voluntary recall from its wholesalers of 18 lots of drugs involving 10 different products.
Lilly said it initiated the recall because some of the manufacturing procedures used for the drugs had not been approved in advance by the Food and Drug Administration, as required by federal law.
Dingell, in his letter to Young, asked for copies of the FDA’s internal reports on a just-concluded agency inspection of Lilly.
The inspection’s findings had led to the recall, Lilly said.
Congressional sources confirmed that the letter was a sign of Dingell’s intent to expand the investigation, saying the lawmaker wanted to look at Lilly to determine whether that company’s problems were unique or indicative of a broader pattern in the manufacture of brand-name drugs.
Dingell has spearheaded a yearlong probe of the generic drug industry that, in conjunction with federal prosecutors in Baltimore, has turned up drug company payoffs to FDA drug reviewers, manufacturing irregularities, paper work deficiencies and testing fraud.
The investigation has also led to the recall of numerous drug products, though there have been no reports of safety problems attributed to the irregularities.
Monday, a senior FDA enforcement official told a hearing of the Energy and Commerce Committee’s Investigations Subcommittee that recent special inspections had turned up manufacturing and paper work irregularities in 11 of 13 generic drug makers that were targeted for review because they were suspected of compliance problems.
