February 19

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Commentary by Vera Hassner Sharav

February 19, 2002
How a New FDA Policy Led toSeven Deadly Drugs


The Seattle Times reports, "Therelationship between the FDA and pharmaceutical industry changed fundamentallyunder former President Clinton, and the agency was forced to speed up drugapprovals, hire staff and become more of a partner and less of an adversary withindustry."

Since Congress passed the Prescription Drug Users Act (PDUFA)in 1992, FDA became a servant of industry, putting industry’s interests ahead ofpublic health safety. As The Seattle Times reports, "The lawhas brought in lots of industry cash…In return for its money, the industry gotwhat it wanted: speedier reviews and more approved drugs."

What the public got was unsafe drugs being approved onlyto be recalled after they killed people.

[See, David Willman’s Pulizer Prize winning series in
The Los
Angeles Times:
How a New Policy Led to Seven Deadly Drugs

~~~~~~~~~~~~~~~~~~~ http://seattletimes.nwsource.com/html/businesstechnology/134407195_fda190.html

The Seattle Times
FDA headache: balancing safety and drug approval

By Luke Timmerman

The U.S. Food and Drug Administration, the world’sforemost protector of public health, is asking the key industry it regulates formillions of dollars more to do its job.

The agency has been collecting industry cash for a decadenow, since Congress passed a law that cut off access to more taxpayer money. Thelaw has brought in lots of industry cash and enabled the FDA to watch drugsafety and effectiveness while getting new drugs to people in need.

In return for its money, the industry got what it wanted:speedier reviews and more approved drugs.

The law that fundamentally changed the FDA expires inSeptember. Lobbyists working for the Seattle biotech industry and big drugcompanies are working quietly to extend it, while the agency wants to gettougher.

But with Americans taking $100 billion in medications ayear and with drug makers writing bigger checks to the drug-safety police, somephysicians wonder whether the FDA can put public health first.

"When I started 20 years ago, the FDA was a littleslow, but they could be counted on," said Dr. Paul Buehrens, medicaldirector of Lakeshore Clinic in Kirkland. "Now they’ve become too fast, andit’s been politicized. I have less faith than I used to."

Whether the FDA regains some leverage this time depends onits ongoing negotiations with the industry and members of Congress over the law,called the Prescription Drug User Fee Act.

Drug companies such as Immunex, Merck and Pfizer want tomake sure the agency has enough money to do quick and consistent reviews. Theirlobbyists say they are willing to pay so long as they get speedy approvals.

The FDA agrees the public needs drug approvals to keepflowing, but the agency also is trying to snag new power over advertising andlong-term safety monitoring.

Reforms won’t come easy, considering the FDA’s moneytroubles. The agency says federal money hasn’t kept pace with its workload, andit is swamped by more than 1,300 drugs being tested on humans. A politicalstalemate has left the agency leaderless for more than a year.

Consumer groups say the FDA is trying to do its job but isin no position to stake out a tough negotiating position against an industrythat pays salaries for 900 — or about 10 percent — of itsworkers and gives it better computers.

Even so, the FDA appears to be swinging the pendulum backfrom speed toward caution. Since the late 1990s, it has had to pull 11 unsafedrugs off the market, and from 1993 to 2000, reports of serious side effectsshot up 89 percent. In 1998, it took about 12 months to review a drug, but thatslowed to about 16 months last year.

Corixa can vouch for the agency’s work burden. The Seattlebiotech is scrambling to get its first drug approved by the FDA, but the agencysays it is too overworked to give the drug a hearing. Companies such as Corixaare under fierce pressure from stockholders to get money-making drugs on themarket, and they are complaining again about regulatory stalling.

Dr. Chris Milne, assistant director of the Tufts Centerfor the Study of Drug Development, said the FDA staff is talking more aboutdistancing itself from the drug industry, but that doesn’t mean cutting itselfoff from industry money.

"Nobody wants to go back to the bad old days ofgovernment funding, where the FDA didn’t have enough staff and wasn’t gettingenough money to do its job," Milne said. "It was a morass."

Consumer groups say it would be ideal if the FDA avoided aconflict of interest and relied solely on taxpayers to pay its bills, but onlypurists still cling to that notion, said Travis Plunkett, legislative directorof the Consumer Federation of America.

Instead, consumer groups have a new strategy: They arebanding together with an odd mix of big health insurers such as Blue Cross/BlueShield and big employers such as General Motors, who want the agency to havemore power to harness runaway drug costs and ensure drugs are safe.

To do that, the business-consumer alliance is supportingthe FDA’s ideas to use its industry cash to start directly monitoring thelong-term safety of drugs on the market. The group also supports the FDA in itsquest for stronger authority over television ads the drug industry uses toencourage patients, pressure doctors and create fresh demand for prescriptiondrugs.

President Bush’s budget proposal for next year would bringthe FDA and drug industry closer. It gives the FDA authority to collect $272million in fees from the drug industry.

The relationship between the FDA and pharmaceuticalindustry changed fundamentally under former President Clinton, and the agencywas forced to speed up drug approvals, hire staff and become more of a partnerand less of an adversary with industry.

In return, the agency got money from the pharmaceuticalindustry, called user fees. The agency used the money to hire staff to keep upwith the growing number of complex drug applications submitted by biotech andpharmaceutical companies.

U.S. Food and Drug Administration

  • Established: 1938
  • Headquarters: Rockville, Md.
  • Employees: 9,000 in 167 U.S. cities.
  • 2003 requested budget: $1.7 billion, an 11 percent increase from 2002.
  • Industry fees: The FDA has requested authority to collect $272 million this year from biotech and pharmaceutical companies to review new drug applications.
  • Responsibilities: Ensure public safety of food, drugs and medical devices. It monitors safety of about $1 trillion of goods a year, about a quarter of all consumer expenditures in the U.S.
  • Drugs and vaccines approved in 2001: 48
  • Experimental drugs in development: 1,300

Sources: Food and Drug Administration, BiotechnologyIndustry Organization, Pharmaceutical Research and Manufacturers Association

In 2000, the FDA was stung by a Los Angeles Timesinvestigation that showed how the agency was forced to pull from the marketunsafe drugs that had been approved under the new policy. The investigationestimated that more than 20 million Americans took drugs the FDA laterconsidered too dangerous.

One was the infamous fen-phen case of a diet drug calledRedux that may have caused fatal heart defects. Another was a diabetes drugcalled Rezulin, which was linked to liver failure.

However, now that the FDA has slowed its reviews, drugcompanies are complaining.

The Pharmaceutical Research and Manufacturers of America,the organization of the country’s biggest drug makers, wants what it calls aclean extension of the law. That means not requiring companies to reduce drugprices or not adding amendments that would open the door to more competitionfrom generic manufacturers, said spokesman Jeff Trewhitt.

Trewhitt says the current close relationship with the FDAhas worked well. He said it provides predictable timetables for drug companiesand has put some life-saving drugs on the market faster.

"We need to protect and maintain the progress thathas been made," Trewhitt said.

The Biotechnology Industry Organization shares itsdrug-industry partner’s bargaining stance. Both groups are skeptical about theFDA watching long-term safety. They also don’t like the FDA’s desire toscrutinize direct-to-consumer advertisements.

Drug-industry critics say while the ads may have helped bybuilding awareness of new drugs, they also may be creating artificial demandwhile glossing over serious side effects.

As recently as August, the agency’s advertising divisioncouldn’t do much about it. The division had only 13 staff members to review32,000 pieces of promotional material, Plunkett said.

Some critics wonder whether the FDA can still be tough.Its clout within government has fallen — the National Institutes ofHealth got an annual budget increase twice as big as the FDA’s entire budget. Atthe same time, the pharmaceutical industry has consistently poured more moneyinto federal elections.

Consumer advocates say that puts the FDA at adisadvantage.

"The FDA does not give campaign contributions orinfluence Congress," said Sidney Wolfe, a longtime FDA watchdog with PublicCitizen. "The industry always has the leverage."

Still, the FDA defended itself while staking out astronger position in a November issue of the Federal Register. The agency saidits approval rate has jumped from 60 to 80 percent of drugs because of bettercommunication with drug companies.

The FDA also listed its woes: It poorly negotiateduser-fee rates in 1997 and could run out of money by September. Its mission ofprotecting public health is potentially compromised because it is underfundedand swamped.

Plus, Janet Woodcock, director of the FDA’s drug-reviewcenter, has said the law has created a "sweatshop" environment at theFDA that has led to high staff turnover.

On its Web site, the agency sends a mixed message.

It touts itself as "one of the most successful andproudest creations of American democracy" and mentions a 1999 poll by thePew Research Center that said the FDA has an overall favorable rating of morethan 80 percent — more than double the approval rate for the entiregovernment.

But any serious reforms clearly won’t happen without afight from industry.

H. Stewart Parker, chief executive of Seattle-basedTargeted Genetics, said the drug industry is not happy with the FDA slowdown.She said there’s a strong chance the industry will be able to get its way.

"We’re willing to pay more if it will expeditethings, but we’re not sure it will," Parker said recently. "There’s noincrease in the federal budget for the FDA, so if we don’t pay, I’m not surewhere the money’s going to come from."

Click here to return tofollow-up (March 8, 2002) article.

Luke Timmerman can be reached at 206-515-5644 or ltimmerman@seattletimes.com.

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