> ## Content Index > Fetch the complete content index at: https://www.fdaweb.com/llms.txt > Use this file to discover other available public pages before exploring further. # Sharfstein et al. Urge Stronger FDA Oversight of Accelerated Approvals - URL: https://www.fdaweb.com/sharfstein-et-al-urge-stronger-fda-oversight-of-accelerated-approvals/ - Published: 2026-10-05T18:15:00.000Z - Updated: 2026-10-05T18:17:00.000Z - Author: David McFarland - Tags: Drugs FDA should strengthen its oversight and enforcement of confirmatory trials for accelerated approval drugs, with Medicare and Medicaid payments limited until the products’ clinical benefits are confirmed, according to a new proposal for expanding the agency's role in addressing drug costs. The proposal is one of several recommendations from former FDA principal deputy commissioner and now-Johns Hopkins Bloomberg School of Public Health vice dean **Joshua Sharfstein** and Johns Hopkins PhD candidate **Caleigh Propes**, who write in an [article](https://bsky.app/profile/drjoshs.bsky.social/post/3mwly5xm3uk2b?ref=fdaweb.com) in the *Journal of Health Politics, Policy and Law* that the agency should “engage with drug pricing as a public health concern.” Regarding the accelerated approval program, the authors call for Congress to authorize FDA to work with the Centers for Medicare & Medicaid Services (CMS) “to limit the Medicare Part B and Medicaid payment rates for accelerated approval products until there has been a confirmation of clinical benefit.” Under their proposal, CMS would exercise the payment authority rather than FDA. The payment restrictions, however, would be tied to enhanced FDA oversight and enforcement of sponsors' obligations to complete confirmatory trials. To illustrate their pricing concern, the journal article notes that between 2012-2020, Medicare paid about $12 billion on cancer drugs that ended up having negative confirmatory trials, and “fewer than half of those treated with accelerated approval drugs received medications that turned out to have overall survival benefit (Naci et al. 2025).” Sharfstein and Propes argue that the accelerated approval program creates a particular pricing problem because manufacturers can charge full market prices while definitive evidence of clinical benefit remains outstanding. The problem can persist after confirmatory evidence turns negative. Drugs receiving accelerated approval remained on the market for an average 46 months following a negative confirmatory trial, the authors say, citing research on withdrawals. The authors contend that allowing manufacturers to charge full market prices immediately after accelerated approval may reduce their financial incentive to complete confirmatory trials quickly. At the same time, patients can face substantial costs for drugs whose clinical benefits remain uncertain. The proposal also intentionally preserves the traditional firewall surrounding FDA's approval decisions. Sharfstein and Propes say price should not influence FDA’s scientific determination of whether a product meets safety and effectiveness standards. Another area requiring increased FDAattention, according to the authors, is addressing more aggressively brand-name manufacturer practices that delay generic competition and keep drug prices high. They point to patent evergreening, in which manufacturers obtain additional patents that can extend market exclusivity, citing research estimating that delayed generic entry associated with extended monopolies cost the U.S. health system almost $54 billion. They say FDA could respond in part by prioritizing review of generic applications in markets characterized by high prices and limited competition. FDA already prioritizes certain applications involving drugs with little competition, but the authors propose going further by systematically tracking drug-price information to identify generic applications that should receive expedited regulatory decisions. FDA could also increase scrutiny of strategies used to delay generic entry. The authors point to the agency's previous use of public “watchlists” involving companies accused of restricting access to drug samples for bioequivalence testing and recommend additional measures, including greater transparency around citizen petitions and streamlining review of complex generics. Some anticompetitive practices would require congressional action. The authors cite so-called “parking” under the Hatch-Waxman Act, in which brand manufacturers can pay generic companies to delay market entry. They support an FDA-requested change to the law's 180-day exclusivity forfeiture provision intended to close a loophole that can be used to delay generic competition. The authors separately propose giving FDA greater ability to use enforcement discretion when extraordinarily high drug prices effectively create an access shortage. They say FDA could temporarily refrain from enforcing certain regulatory requirements to permit an alternative supply of a drug when price prevents significant numbers of patients from obtaining an otherwise available medicine. The paper likens this to FDA's existing responses to conventional drug shortages. FDA permits compounding under shortage circumstances and has sometimes allowed temporary importation of unapproved foreign products when domestic supplies are inadequate. Congress could extend that concept to what the authors describe as an artificial shortage resulting from extraordinary prices that create significant barriers to access. Such a policy would carry risks. Compounded and imported medicines may not be subject to the full range of FDA safeguards applicable to approved products, while importation over an innovator manufacturer's objections could raise supply-chain concerns. The authors therefore envision Congress authorizing FDA to weigh those quality and safety risks against the public-health consequences of patients being unable to obtain treatment because of price. Anotherrecommendation calls for FDA to make more of the clinical data it receives available for independent economic and value assessments. FDA possesses extensive safety and effectiveness data submitted for new and existing drugs. Sharfstein and Propes argue that responsibly sharing de-identified clinical-trial data with qualified researchers and organizations could improve scientific understanding while giving health technology assessment groups, payers and state prescription drug affordability boards better evidence for evaluating drug costs and value. They recommend FDA release reports and make more pre-market and post-market clinical-trial data available. Such disclosure could fill gaps in existing data and improve U.S.-focused assessments of drug safety, efficacy and value, they contend. The transparency proposal goes beyond clinical-trial data. Propes and Sharfstein also call on FDA to make existing resources such as the *Orange Book* easier to use for pricing analysis. Currently, organizations conducting price reviews may need to purchase information from costly third-party data vendors, limiting who can conduct those analyses. Improving FDA databases could also help manufacturers and researchers identify opportunities for additional competition. The authors acknowledge that greater transparency would not necessarily produce lower prices. A value assessment could conclude that a high price is justified and potentially support a higher price. Their objective is better alignment between price and therapeutic value rather than simply lowering every drug's price. FDA already has authority to release considerably more clinical-trial information to qualified researchers, according to the paper, although manufacturers could challenge such disclosures in court and patient privacy would have to be protected. Congress could clarify FDA's authority and direct the agency to establish new data-sharing programs, including providing clinical-trial information to health technology assessment organizations for independent value assessments following approval, they write. Despite calling for a substantially larger FDA role in drug-pricing policy, Sharfstein and Propes draw a firm boundary around the agency's core scientific functions. They oppose allowing a drug's price to change the outcome of FDA's review of preclinical and clinical evidence and say they would not support Congress amending the law to make price an additional factor in drug approval or clearance decisions. Instead, their proposed framework would allow FDA to consider pricing when its policies can improve competition, patient access and transparency, or encourage timely completion of clinical studies, while maintaining the firewall around the agency's ultimate safety and effectiveness determinations.