Trends to Watch
New Study Finds Drugs Approved Under Deadline Face Problems Later
A new study has found that drugs that are approved quickly to meet mandated deadlines are more likely to run into trouble down the line, after they are in millions of Americans' medicine cabinets, than drugs that receive more deliberation before approval. The study entitled, "Drug-Review Deadlines and Safety Problems", was published in the March 27 edition of the New England Journal of Medicine found that “once medications are in clinical use, the discovery of safety problems is more likely for drugs approved immediately before a deadline than for those approved at other times.” "It's not necessarily the case that these drugs should not have been approved, but it may have helped to have a black box warning in the first place rather than adding one three years later," said study author Daniel Carpenter, a professor of government at Harvard University as quoted in Forbes.
The hurry to approve the drugs is the result of provisions in the 1992 Prescription Drug User Fee Act (PDUFA) which mandated that the Food and Drug Administration must act on 90% of all drug applications within 12 months of submission of the application or face funding cuts. Moreover, the time for approval was further reduced in 1997 to just 10 months. After PDUFA’s passage, the study found that drug approval decisions tended to be concentrated in the two months preceding the deadlines. Of those drugs approved just prior to the deadline, they were “more than five times more likely to be withdrawn from the market for safety reasons; more than four times more likely to have to add a black-box warning; and more than three times more likely to have one or more dosage forms voluntarily discontinued by the manufacturer.”
U.K. Plans to Force Drugmakers Share Clinical Trial Information
The government of Great Britain plans to force pharmaceutical companies to share more information with regulators about clinical trials by years-end after a recently concluded investigation found that a major drugmaker deliberately withheld information about an antidepressant and its effect on increasing the suicide risk of teenagers. Government officials were reacting to the findings of a four-year probe by the U.K. Medicines and Healthcare products Regulatory Agency which said that GlaxoSmithKline PLC should have revealed more quickly information indicating that Seroxat can increase the suicide risk in teenagers — by more than six times. But the agency declared that “on the basis of the investigation findings and legal advice, is that the case should not proceed to prosecution” without stronger legislation in place.
"I remain concerned that GSK could and should have reported this information earlier than they did," MHRA chief executive Kent Woods said in a press statement. However, GlaxoSmithKline rejected the suggestion that it withheld information and offered comments that it “acted properly and responsibly.” According to a March 24 Associated Press report, in response, the British Minister of State for Public Health said that the government will tighten laws forcing companies to share all their relevant safety research with regulators by the end of 2008. “Companies that conduct clinical trials should not compromise people's health by withholding information," said the Rt. Hon. Dawn Primarolo, MP (Labor) and the new laws will require companies to disclose a drug's side effects in all patients tested.
Eshoo and Barton Introduce New Biologics Bill in House
A long-awaited bipartisan bill giving FDA the authority to approve follow-on biologics was finally introduced in the House on March 13 and added another option for Members on this controversial issue. Rep. Anna Eshoo (D-CA) and Rep. Joe Barton (R-TX) were able to introduce the bill with 6 Democrats and 6 Republicans as original cosponsors. According to an Eshoo release, the Pathway for Biologics Act (HR 5629) would permit the FDA to make a determination as to whether the biosimilar is interchangeable with the reference product, and gives the FDA the flexibility to determine what clinical testing – if any – is required for approval. To promote continued innovation in biotechnology, the legislation provides 12 years of data exclusivity to allow innovators to market their products and recoup their investments in research and development. Finally, to prevent uncertainty and delays over patent litigation, the bill establishes a process for resolution of patent disputes prior to the time biosimilar products are eligible to come onto the market.
On the House side, two other biogenerics bills have been introduced. One is HR 1038 which was introduced by Rep. Henry Waxman (D-CA) in February 2007 which does not give brand biologic makers an exclusivity period during which they can recoup some of the cost of innovation. Waxman's bill has 6 Republican and 22 Democratic cosponsors and has already been the subject of Congressional hearings. Moreover, a key committee member has cosponsored the bill: Energy and Commerce Health Subcommittee Chairman Rep. Frank Pallone (D-NJ). The other bill is HR 1956 which was introduced by Rep. Jay Inslee (D-WA) in April 2007 and would offer 14 years of exclusivity. This measure has 16 Democratic co-sponsors.