Rx Accountable

Thousands of Americans die every year from taking prescription drugs, and millions more are hospitalized. This isn’t an aberration; it is a feature of a crony medical system in which the agency that is supposed to evaluate and approve drugs is beholden to the pharmaceutical industry. ANH is launching a campaign to remove cronyism from the drug approval process and require transparency on drug labels when a drug is newly approved. We’re also launching a legal initiative to help get dangerous drugs off the market.

The fundamental problem is the FDA approval process itself. The data suggest that drug safety has suffered since the passage of the Prescription Drug User Fee Act of 1992 (PDUFA). This law called for drug companies to pay user fees to the FDA to fund drug approval. (This is one of the lynchpins of the crony medical system because it makes the FDA financially beholden to the industry it is meant to regulate.)

What has PDUFA done for safety? A JAMA study found that nearly a third of drugs approved by the FDA between 2001 and 2010 had a post-market safety event. Drugs approved after the enactment of PDUFA were more likely to receive a black box warning or be withdrawn.

The standards for drug approval also leave much to be desired. As of 2014, 37 percent of approved drugs were backed only by a single study; 68 percent compared new drugs only to placebo, meaning that the drug was better than nothing but not necessarily better than a drug already on the market. Pre-clinical trials for drugs suffer from many shortcomings: they’re too small to give a proper estimate of adverse events, some last only a few months when some side effects occur only after several years, and many trials select healthy participants to show a drug works, which doesn’t reflect the drug’s use in the real word.

Nor does the FDA do a proper job of monitoring the drugs it approves. For this task, the most important tool in the FDA’s toolbox is their adverse event reporting system (the FAERS database). This database relies on patients, doctors, and drug manufacturers (who are required by law to submit adverse events they receive to the FDA) to send information about dangerous drugs to the agency’s database. The FDA then determines, on a product by product basis, how seriously to monitor adverse event reports.

There are several obvious problems with this approach, as experts have pointed out. Underreporting is the biggest one; it’s estimated that between 1 and 10 percent of adverse events are reported to the FDA every year. Adverse event reports also are not standardized—different names for the same drugs and the use of different clinical terminology can make the FAERS system difficult to search. There are also delays. FAERS is updated only once every quarter, prolonging the time that Americans are exposed to dangerous drugs.

The Government Accountability Office (GAO) also found serious problems with the FDA’s post-market safety monitoring of drugs. In a 2015 report, the GAO concluded:

FDA lacks reliable, readily accessible data on tracked safety issues and post-market studies needed to meet certain post-market safety reporting responsibilities and to conduct systematic oversight…[These problems] have restricted the agency’s ability to perform systematic oversight of post-market drug safety.

The FDA is required to routinely monitor and analyze FAERS and publish quarterly reports on new safety information and potential risks they uncover, but this process is slow and does not meaningfully keep patients in the loop. Consider Uloric, a gout medication approved in 2009 that is currently facing a number of lawsuits after studies have shown the drug can cause serious heart problems. The FDA first noticed an issue in 2011, when the agency’s post-market surveillance analysis added an additional side effect to the drug’s label. It wasn’t until 2019, however, that the FDA added a black box warning to Uloric for increased risk of death; that is, ten years after the drug is approved, the FDA warns us of serious, life-threatening risks with the drug. Something is seriously wrong here.

In light of the myriad problems with drug review and post-market safety surveillance, ANH-USA is supporting three key reforms to help Americans avoid dangerous drugs:

  • More transparency in post-market surveillance. In its quarterly reports on drug safety surveillance, the FDA routinely states that it is “reviewing the need for further regulatory action.” How many of these drugs, like Uloric, will eventually get a black box warning, or additional side effects added? When the FDA is reviewing an approved drug for additional safety concerns, this information should be meaningfully communicated to the public so patients can make their own decisions, in collaboration with their doctors, about whether to continue taking the drug. Additionally, doctors should be required to alert patients when the FDA is reviewing an approved drug for additional safety concerns early in the review process.
  • Mandatory labeling identifying newly approved drugs. Given the safety issues with many new pharmaceutical products, drugs should carry labeling that identifies the product as a new drug that has undetermined side effects. Doctors prescribing these drugs should also be required to inform patients that the drugs are recently approved and may have side effects beyond those currently identified in the drug’s insert. This will empower consumers to start a conversation with their health care providers about the potential benefit of taking a drug that has been on the market longer with a more established safety profile. This is already done in the United Kingdom and was even recommended by the Institute of Medicine in 2007, but the FDA did not adopt the labeling measure.
  • Third party drug testing. Because of the user fee system, it is clear that the FDA is compromised in its ability to assess the safety and efficacy of drugs. Currently, drug companies submit their own studies for FDA approval and can hide studies that show danger. A third-party review system would eliminate this obfuscation and make drug approval more transparent. Universities or other qualified parties could contract with the government to anonymously review drugs and devices. Drug companies would pay up-front for the cost of reviewing and approving drugs without knowing which entity would be doing the work. This change will eliminate cronyism in the drug approval process.
  • Allow free speech about supplements. Another linchpin of our crony medical system is that the FDA protects drug monopolies by throttling natural products. Because synthetic drugs can be patent-protected, drug companies can afford the astronomical costs of FDA approval; only FDA-approved drugs can claim to treat or prevent disease. Supplements, as natural compounds, generally cannot be patented (or can only receive weaker patents compared to drugs), thus cannot go through FDA approval. So even though there is strong scientific evidence backing the use of supplements to help prevent or treat a host of illnesses (like vitamin D and the flu), the FDA makes sure the public cannot know of these benefits, leading many people to buy dangerous drugs. Allowing natural products to communicate the scientifically-proven benefits they can confer will help break the drug monopoly on healthcare.

While we fight to improve the system for how drugs are approved, labeled, and monitored, we’re also launching a new legal initiative to get dangerous drugs off the market. Our Legal Center offers information on lawsuits that are in progress on dangerous drugs and the injuries they cause. If you or someone you know has taken any of these drugs, you may be able to help us get these products off the market.

Surveys have found that 55 percent of Americans regularly take prescription drugs; those who do take an average of four prescription drugs. It is our families, friends, and loved ones taking these medications, and the preceding data should alarm all of us. The FDA is approving dangerous drugs and then not monitoring them properly, and we’re paying the price. According to one report, each year more than 2 million people suffer an adverse event from a drug and 100,000 people die. This is completely unacceptable.

Action Alert! Write to Congress and the FDA, urging them to support key reforms to the drug approval system and post-market safety surveillance. Please send your message immediately.