(Bloomberg) -- Since 2012, an increasing number ofdrugs have been approved by U.S.regulators through programs meant to speed them to market.

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It’s good news for patients who benefit sooner from potentiallylife-saving treatments.

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The downside, a government watchdog agency said Thursday, isthat the Food and Drug Administration hasn’tbeen keeping up with monitoring what happens after thedrugs are being prescribed topatients--as it should.

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The Government Accountability Office, Congress’s investigativearm, found shortfalls in the FDA’s ability to track whether safetyissues arose or check that drugmakers conduct additional trialswhen they are needed.

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“The GAO report confirms my greatest fear, that FDA lacksfundamental resources and leadership in ensuring that drugs broughtquickly to market are truly safe and effective,” said CongresswomanRosa DeLauro, a Democrat from Connecticut who asked for thestudy.

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“If FDA is shifting more of the safety risk to consumers byallowing fewer and shorter clinical trials on expedited drugs,adequate tracking of drug safety issues and review of post-marketstudies are absolutely vital.”

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The report highlights the tension between the urge to speed upreviews for ground-breaking treatments that can save many lives andthe potential risks those drugs, which on average get approved 31/2 months faster than through regular FDA programs, may pose downthe road.

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Cancer treatments, in particular, havebenefited from a sharp acceleration in approval times in recentyears under the leadership of Richard Pazdur, the FDA’s director ofthe office of hematology and oncology products.

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It enabled a drug like Bristol-Myers Squibb Co.’s Opdivo to becleared months ahead of schedule to treat a form of lungcancer.

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What the GAO report pointed out is the FDA’s lack offollow-ups.

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The agency can request that drugmakers conduct further studieson treatments once they’re for sale.

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Yet more than half of submissions by pharmaceutical companiesfrom March 2008 to September 2013--related to 1,400 post-marketstudies--were either reviewed late by the FDA or not reviewed atall.

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The FDA said in a response posted by the GAO that it has beenworking to improve its tracking and assessment abilities. Drugsapproved through expedited programs must meet the same standardsfor safety and effectiveness as other drugs, the FDA added.

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About a quarter of the 1,717 drugs approved from Oct. 1, 2006through Dec. 31, 2014 went through at least one of the FDA’s fourexpedited programs--which are priority review, acceleratedapproval, breakthrough and fast track.

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Those drugs underwent 8.6 months of review on average comparedwith 12.1 months for the others, the GAO said. Oncology was thebiggest category for speedier reviews.

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Better drugs

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In 2015, the FDA approved 30 drugs for cancer, which is morethan three times the number in 2009, a decade low.

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In an interview before the report came out, Pazdur said thescience around cancer has improved drastically, allowing him tomove treatments to patients much faster because drugmakers are ableto better target those who will benefit.

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“The drugs got better,” Pazdur said. “When I first came here, itwas ‘Well, should we approve a drug or not?” he said. Now, withtreatments that more effective and more tolerable, “it’s notso much a question of should we approve the drug, but how fast canwe approve,” he said.

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His career epitomizes the recent changes in the FDA reviewprocesses. Earlier in his 16-year tenure, Pazdur was cast as abarrier to getting much-needed cancer medications to patients.

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Now, he’s praised for his fast-track approvals. Pazdur knowsfrom a personal level, too, having lost his wife to ovarian cancerin November, which he says gave him “a sense of urgency that thingshave to be done.”

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Improve oversight

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Although patients benefit from new treatments, not everyonethinks faster means better.

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The FDA often approves drugs for cancer based on what are calledsurrogate endpoints -- for example, a tumor shrank or grew moreslowly during clinical trials. But endpoints like a tumor size maynot correlate with survival, said Vinay Prasad, an oncologist withthe Knight Cancer Institute at Oregon Health and ScienceUniversity.

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Of 54 cancer treatments the FDA approved from 2008 through 2012,67 percent were cleared based on a surrogate endpoint, according toa paper Prasad co-authored in the American Medical Association’sjournal of internal medicine.

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After a median follow-up of 4.4 years, five drugs were shown toimprove survival, 18 drugs failed to do so and 13 had unknownsurvival effects, meaning either the companies hadn’t tested themfor that or hadn’t reported the results.

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The GAO had raised concerns in 2009 about the FDA’s reliance onsurrogate endpoints, saying the agency needed to enhance theoversight of post-market studies on those drugs.

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In the report Thursday, the GAO recommended the FDA developplans to better track drugs once they’re on the market, includingimproved databases on safety issues.

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