The US government will begin investigating the cause behind persistent shortages of generic drugs that are “seriously endangering” patients’ lives.
The joint investigation by the Federal Trade Commission and the US Department of Health and Human Services will aim to “understand how the practices of two types of pharmaceutical drug intermediaries – group purchasing organizations (GPOs) and wholesalers – may be contributing to generic drug shortages. ‘
GPOs are organizations that negotiate drug prices between manufacturers and doctors or hospitals; They do not buy products directly. The groups work to lower drug prices and reduce costs by increasing the amount a healthcare provider will purchase.
Drug wholesalers buy drugs directly from manufacturers and sell them to suppliers. Its goal is to ensure that a certain amount of a manufacturer’s generic drugs are distributed in an effort to reduce drug prices.
The number of drugs in short supply has reached an all-time high, forcing patients with cancer and chronic illnesses to choose between waiting more than a year for life-saving drugs or paying thousands of dollars for alternatives. .
Doctors have also said they have had to ration chemotherapy drugs and make life-and-death decisions when choosing which patients to prioritize for potentially curative therapy.
At the end of 2022, shortages reached a five-year high, with 295 active shortages reported.
Experts have attributed the shortage to increased reliance on foreign manufacturers, manufacturing quality issues, supply chain problems resulting from a lack of raw materials and natural disasters, and pressure for more brand-name (and more expensive) drugs in instead of cheaper generic versions, which creates a race. downward effect on the pharmaceutical market.
The government cannot force a manufacturer to produce a generic drug, which is cheaper, available from several companies and makes up 90 percent of the medications Americans take.
Instead, manufacturers often discontinue generics in favor of their own proprietary, brand-name version, which will allow them to make much more money.
This allows the company to create a monopoly on the drug, forcing people to spend thousands of dollars because the drug is not available from other manufacturers.
The goal of the FTC and HHS investigation is to understand how GPOs and wholesalers impact the availability (and therefore price) of some of the country’s most popular medications.
FTC Chair Lina Khan said: ‘For years, Americans have faced severe shortages of critical medications, from chemotherapy to antibiotics, putting patients at risk.
‘Our investigation seeks information on the factors driving these shortages and examines the practices of opaque drug intermediaries. “We look forward to receiving public feedback as we evaluate how policymakers and authorities can better address chronic drug shortages and promote a resilient drug supply chain.”
Drug shortages increased nearly 30 percent between 2021 and 2022 in the US, reaching a five-year high 295, according to official government figures.
A Senate report last year found that more than 15 of those drugs have been experiencing shortages for more than a decade, compared to the average shortage duration of 1.5 years.
TOand a recent American Cancer Society survey It found that one in 10 patients have been affected by shortages, forcing them to use substitute drugs or delay treatment.
Most of the drugs in short supply are generic drugs, meaning they cost the patient and the insurer much less than brand-name versions.
Officials hope their efforts will promote competition in the pharmaceutical industry to keep prices low and increase access to life-saving drugs.
As part of the agencies’ request, they are seeking public input and comments on various issues related to generic drug markets and possible causes of shortages.
Some of the issues include: the extent to which GPOs and wholesalers are meeting their legal obligations; whether concentration of the drug market between GPOs and wholesalers has impacted smaller health care providers and rural hospitals; and to what extent entities have discouraged drug suppliers from competing in the generic market.
The drug shortage crisis, which is affecting the United States more than any other Western nation, has caught the attention of American politicians.
In December, the US Senate Finance Committee held a session dedicated to the issue, featuring alarming testimony from doctors on the front lines of the crisis.
Dr. Jason Westin, director of the lymphoma clinical research program at MD Anderson Cancer Center in Houston, said, “The absence of cheap, generic drugs like fludarabine (used to treat blood cancer) can literally make the difference between life and death”.
Westin added that patients with aggressive blood cancers do not have time to wait for drugs that are in short supply, because there is often a narrow window in which patients can receive life-saving medications.
He said: ‘My colleagues have been forced to make impossible decisions, including choosing which patients will be prioritized for potentially curative therapy.
‘We know how to treat cancer, but shortages force us to make impossible decisions. We have life-saving medicines and life-threatening shortages.’
Experts say a major factor is the United States. the government’s inability to regulate profit-hungry pharmaceutical companies, unlike other nations.
The federal government does not control raw materials for drugs or oversee manufacturing processes that may take place abroad.
This means Pharmaceutical companies may claim that supply chain problems are to blame for shortages, when in reality they may have discontinued drugs because they are less profitable than others.
And the Food and Drug Administration (FDA) said the shortage could be due to companies discontinuing older generic drugs that are no longer profitable in favor of brand-name drugs that will make more money.
Management states: ‘Discontinuations are another factor contributing to the shortage.
‘The FDA cannot require a company to continue making a drug it wants to discontinue. Companies sometimes discontinue these older drugs in favor of newer, more profitable drugs.’
Newer brand-name drugs tend to be more profitable than older generic versions, which make up 90 percent of the drugs Americans take.
This is because new, more expensive drugs have patents that last for years, meaning they can only be manufactured by one company and at the same price.
Older drugs have expired patents, meaning multiple companies can make generic versions, driving down the price.
Another factor driving the problem is the United States’ dependence on key materials from China and India to manufacture 95 percent of the drugs used in emergency care.
Foreign manufacturers registered with the FDA have more than doubled between 2010 and 2015.
The FDA already has limited oversight of drug manufacturing, but shifting those responsibilities to foreign entities further complicates the process because the United States has no knowledge of the quality of foreign manufacturing or supply chain issues.
In an effort to increase access, the FDA granted Florida permission last month to be the first state to be allowed to import less expensive drugs from Canada, in a major policy change that could allow Americans to access more expensive versions. cheap medications that cost thousands of dollars.
While people in the United States can make direct purchases from Canada, the decision will make Florida the first state to be allowed to buy less expensive drugs in bulk from Canadian wholesalers.