OpenFDA and the Future of Drug Safety Information

The FDA has collected millions of records on adverse drug events since 1998, amounting to the world’s largest catalog of how drugs interact with the human body. The FDA publishes bulk files on a quarterly basis; however, it takes a great deal of expertise and software to understand the data. Also, the information is extremely inaccessible for anyone outside the FDA (e.g., viewing a report on a specific drug requires a Freedom of Information Act request), making it almost impossible for everyday citizens and physicians to make informed decisions about prescription drugs.

In January 2014, the FDA began the openFDA project to release datasets covering adverse drug events, recalls, and drug documentation. Beta access to the database is expected by this summer, followed by a full launch in the fall. 

Startups have tried to use the FDA’s bulk files to provide information for consumers and clients in the health care industry. For example, AdverseEvents creates reports based on the FDA’s bulk files for insurers and hospitals. DrugCite allows users to search for side effects by medications online. Founders from both organizations have expressed frustrations with the current FDA data, citing challenges such as duplicate records, misspelled drug names, and piecemeal files. Once openFDA is launched, more entrepreneurs and software developers will likely create websites and applications to satisfy the public demand for drug safety information.

Article

More on FDA’s Approval of Zohydro

Listen to today’s NPR story on the controversial opioid Zohydro here.

FDA Evaluates Generic Drugs in Widespread Testing

In September 2013, the FDA began allocating $20 million to the quality testing of generic drugs across the US. Previously, generic drug testing was only performed occasionally in the US due to limited resources. However, new fees collected from the generic drug industry have enabled the FDA to undertake large scale quality control efforts. The program began without any public notice, but FDA officials recently confirmed that at least a dozen academic centers are participating in a testing program that will run through 2017. Research this year will focus on heart drugs, ADHD treatments, immunosuppressants, anti-seizure medicines, and antidepressants.

Article

Prevalence and Impact of Multiple Opioid Providers in Part D

A new study analyzed the opioid use of a random sample of approximately 1.8 million Medicare Part D beneficiaries who had least one prescription for an opioid in 2010. The authors found that about 40 percent of opioid utilizers received opioid prescriptions from multiple providers, and that the number of unique opioid providers was strongly correlated with opioid-related hospital admission rates.

Of the approximately 1.8 million beneficiaries who filled at least one prescription for an opioid, 23.1 percent filled prescriptions from two providers, 9.5 percent from three providers, and 7.9 percent from four or more providers. Of the approximately 1.2 million beneficiaries who filled more than one opioid prescription, 34.6 percent filled prescriptions from two providers, 14.2 percent from three providers, and 11.9 percent from four or more providers.

Among patients using the same quantity of prescribed opioids of over the course of a year, those who had four or more providers had twice the annual rate of opioid-related hospital admission than those with only one provider. Beneficiaries who received opioids from multiple providers were on average likelier to receive more opioid prescriptions per year and concurrent opioid prescriptions. They are also less likely to have a single dominant opioid prescriber. The authors found that among beneficiaries receiving opioid prescriptions from four or more providers, the dominant provider was responsible for less than half of the average total number of opioid prescriptions per beneficiary.

While multiple provider opioid prescribing can be a sign of potential prescription drug abuse, it can also indicate fragmented care, which puts beneficiaries at a greater risk of adverse outcomes. To read more about the study, click here.

FDA Plans to Strengthen Regulatory Presence

Following the ban of the fourth Ranbaxy Laboratories facility and growing concerns about the safety of imported drugs, the FDA announced yesterday that it will strengthen its regulatory presence in India. FDA Commissioner Margaret Hamburg conducted an 8-day visit of India, meeting with various drug companies and affiliated groups to discuss manufacturing quality. 

Read More

Furthermore, the FDA released plans to establish an Office of Pharmaceutical Quality to improve oversight of brand, generic, and OTC drugs. The FDA is currently working with the pharmaceutical industry to determine quality indicators and create data collection processes. Also, Congress has a briefing scheduled for February 26th on the subject of substandard generic drug imports.

Read More

Medicare-Medicaid Coordination

More states are creating health care options designed to provide effective, cost-efficient care for beneficiaries who quality for both Medicare and Medicaid. Dual eligible beneficiaries generally account for a disproportionately large share of Medicare and Medicaid program costs. The lack of coordination between the two programs, such as conflicting financial incentives and regulations, may have cost the states and the federal government billions of dollars. The Medicare-Medicaid Coordination Office, which was established under the Affordable Care Act, selected 15 states to receive up to $1 million to support proposed health plans designed for dual eligible individuals. The outcomes of these 15 proposals, along with other state initiatives, could provide interesting insight on how to best provide care for dual eligible beneficiaries. 

Read more

 

GAO Report: The FDA is Preventing More Drug Shortages, But Number of Drug Shortages Remains High

02/18/2014 update: click here to listen to an interview with Sabrina Tavernise, the author of the New York Times piece on the recent GAO report

According to the GAO, the FDA prevented 154 potential drug shortages in 2012, compared with just 35 in 2010. This improvement can be attributed to a 2012 law that required drug manufacturers to notify the FDA about potential and current shortages of drugs that are life supporting, life sustaining, or used to treat debilitating health issues.

However, the number of drug shortages still remains high. There were 456 new and long-term shortages in 2012, nearly triple the 154 shortages in 2007. The GAO report recommended that the FDA improve its data collection and accuracy to better understand and address the factors contributing to drug shortages. But, the report also acknowledged that the FDA did not have control over the business decisions of drug manufacturers. Unfortunately, factors such as a low profitability or limited production capacities can make a drug prone to shortages.

Article

Recent Initiatives to Reform Medicare Payment Process for Physicians

Repealing the “Sustainable Growth Rate”

Today, bipartisan leadership introduced legislation that would repeal the “sustainable growth rate” (SGR), the 1997 formula that currently determines Medicare Part B physician payment rates. Instead, physicians would receive an annual 0.5 percent increase over the next five years as a “pay for performance” type model is phased in by CMS.

The SGR links physician payment to an economic growth target, so in times of strong economic growth where spending is below target, physicians would receive pay increases. However, in 2002, poor economic performance led to a 4.8 percent cut in all physician fees. Since then, Congress has delayed the cuts mandated by the SGR, which reached a steep 24.4 percent in January, out of fear of driving physicians away from Medicare. Because Congress repeatedly overrode SGR mandated cuts, there is now an enormous gap between actual Medicare spending and the amount determined by the SGR formula. The Congressional Budget Office estimates that repealing the CBO could cost between $116 to $150 billion over the next decade.

Doctors Abusing Medicare Face Fines and Expulsion

In a January 15 directive, CMS administrator Marilyn B. Tavenner ordered new steps to identify and punish providers who repeatedly overcharge Medicare patients or provide services substantially in excess of patient needs. Federal officials estimate that 10 percent of payments in the traditional fee-for-service model are improper, suggesting at least $6 billion in improper physician payments annually. “Recalcitrant providers,” meaning those who abuse the Medicare payment system and do not improve after extensive education, will be referred to Daniel R. Levinson, the inspector general at the Department of Health and Human Services. Levison has the authority to impose civil fines and exclude providers from Medicare, Medicaid, and other programs. There is some disagreement on how to screen for “recalcitrant providers”; one possibility is the use of cumulative payment thresholds for each specialty to identify and then investigate providers who exceed the threshold. 

Also, effective March 18th, CMS will have the ability to release data on how much Medicare paid individual doctors. Such information could be useful to consumers, as well as researchers who can help CMS identify fraud and abuse. Physician groups, however, are voicing concerns about privacy and the possible spread of inaccurate, misleading analysis. 

These initiatives mirror CMS’ proposals for the Medicare Part D 2015 Contract Year. The policy changes included measures to increase CMS’ authority to investigate and punish providers who abuse the Part D payment system and/or prescribe inappropriately. CMS also proposed the release unencrypted prescriber identifiers and pharmacy identifiers to a broader audience of requestors with the goal of encouraging external researchers to investigate areas of Part D integrity and quality.

FDA Prohibits 4th Ranbaxy Facility

On January 23, 2014, the FDA banned another Ranbaxy Laboratories, Ltd. facility from producing and distributing drugs for the U.S. market. The FDA inspection unveiled serious violations, including misreported and manipulated test findings. Since 2008, the FDA has prohibited four facilities from the major Indian generics manufacturer, and the company has paid $500 million fines, forfeitures, and penalties-  the largest amount ever levied against a generic manufacturer- after pleading guilty to “selling adulterated drugs with intent to defraud, failing to report that its drugs didn’t meet specifications, and making intentionally false statements to the government.” To read more about fraud at Ranbaxy, click here.

More than 80 percent of active pharmaceutical ingredients as well as 40 percent of finished drug products come from overseas, highlighting the need for increased FDA efforts abroad to ensure prescription drug safety. The Government Accountability Office (GAO) found in 2009 that regulators inspected only 11 percent of foreign drug manufacturing plants, as opposed to 40 percent of domestic plants. The FDA has worked to bring foreign inspections to the same standards as domestic ones, recently allocating resources to increase their presence in China. However, as noted by the GAO, logistical issues prevent the FDA from conducting thorough and unannounced inspections overseas as it does for domestic manufacturers.

The FDA is currently researching the impact of the most recent Ranbaxy ban on domestic drug supplies. But stories such as Ranbaxy’s can also have a negative effect on consumer confidence and willingness to use generic drugs.

FDA Press Release