Utilize Catherine Eban’s website guide (CatherineEban.com) to learn how to investigate your own medications, beginning with identifying the manufacturer of your specific drug.
When picking up a generic prescription, always ask your pharmacist for the manufacturer’s name and inquire about other available manufacturers, as this information is crucial for informed choices.
When available, prioritize ‘authorized generics’ because they are produced by a generic company in partnership with the brand-name manufacturer, often using the original drug recipe, which may indicate higher quality.
Opt for an independent brick-and-mortar pharmacy to facilitate direct conversations with a pharmacist about drug manufacturers and quality, which can be more challenging with large chain pharmacies.
Medical practices should perform thorough due diligence on all prescribed generic drugs by identifying manufacturers, researching public filings, and creating a ‘probabilistic heat map’ to inform safer prescribing choices.
Physicians should expand their diagnostic approach to include the quality of the drug supply, especially when patients become unstable after switching from brand-name to generic medications.
Physicians should investigate when objective lab results do not respond as expected to a generic drug, considering if the patient is taking the medication or if the generic itself is ineffective.
Patients and physicians should be aware that generic extended-release drugs may not work as effectively or could cause different side effects compared to their branded counterparts.
Exercise extreme caution regarding drug quality from manufacturing plants in India and China, as extensive inspections revealed endemic data fraud and manipulation in four-fifths of facilities.
Take personal responsibility for understanding your medication supply by actively paying attention to who manufactures your drugs and how they are intended to function, rather than assuming equivalence.
Utilize apps like GoodRx to compare medication prices across various pharmacies, which can be particularly useful when opting for independent brick-and-mortar pharmacies.
If you have a preferred generic drug manufacturer based on your research, ask your pharmacist if they can order that specific product from their wholesalers.
Be aware that egregious forms of data fraud, including shredding documents, employing data fabrication teams, and conducting secret tests, are endemic in Indian and Chinese drug manufacturing plants.
Be suspicious of data that appears ’too perfect’ or exactly matches expected results, as this can be a significant red flag for manipulation or fraud.
Be vigilant against minor infractions and their rationalizations, as they can lead individuals and organizations down a ‘slippery moral slope’ towards significant corruption and unethical behavior.
If you uncover severe ethical violations that compromise public health, follow your conscience and take action, even if it entails personal risk or difficulty.
Recognize that 80% of active ingredients and the majority of generic drugs in the U.S. supply, including antibiotics, are sourced from overseas, primarily India and China.
Cultivate a strong ‘culture of compliance’ within organizations through consistent training, ethical reinforcement, and the presence of vigilant regulatory oversight to ensure adherence to rules and standards.
Advocate for increased funding, resources, and authority for critical regulatory bodies like the FDA, as they are often under-resourced despite safeguarding a significant portion of the economy and public health.
Advocate for granting subpoena authority to regulatory agencies like the FDA, as their current lack of this power can significantly hinder investigations into corporate misconduct.
Advocate for a system that holds brand-name companies responsible for the quality and authenticity of their authorized generic products, creating a dual layer of oversight beyond regulatory bodies.
Support ongoing congressional efforts to investigate and address problems within the drug supply chain, particularly when FDA findings of egregious conditions are reportedly downgraded.
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Feel free to openly share your enthusiasm for products you genuinely love and use, even without financial affiliation, as Peter Atiyah does with Topo Chico.
Recognize that it’s normal to still experience strong emotions like anger, even if you practice mindfulness, as exemplified by Sam Harris.
If you receive consistent and numerous complaints about a product or service, especially when official explanations are dismissive, consider engaging investigative resources to uncover the truth.
When a credible source presents a significant and intriguing problem, trust your intuition if it suggests there’s substantial depth to the issue, prompting further investigation.
When assessing product quality, especially for complex items like drugs, prioritize evaluating the integrity and control of the manufacturing process, as ’the process is the product.’
For effective inspection or auditing, move beyond simple checklists to scrutinize underlying procedures and critical operational parameters, rather than just visible outcomes.
Recognize that effective regulatory oversight and quality control should extend to all raw materials and components entering a manufacturing process, not just the final production site.
When protecting intellectual property, evaluate whether to use trade secrets for perpetual secrecy or patents for limited-term protection with disclosure, considering the long-term implications for your business.
Brand-name companies should strategically patent multiple aspects of a drug, including formulations and manufacturing steps, to create a comprehensive ‘patent thicket’ for extended protection.
Generic drug manufacturers can legally circumvent existing patents by reverse engineering branded drugs and reordering manufacturing steps to achieve the same end product.
Generic drug manufacturers must independently develop their formulations, including excipients, dissolution profiles, and stability data, as the proprietary ‘drug master files’ of brand-name companies are not disclosed.
Be aware that generic drug approval involves both a review of submitted data in an Abbreviated New Drug Application (ANDA) and a pre-approval inspection of the manufacturing facility.
Generic drug companies should prioritize being the first to file and secure approval for a drug, as this grants a lucrative six-month market exclusivity period allowing for significant profitability.
If you suspect regulatory corruption or unfair competitive practices, consider hiring private detectives to uncover evidence, as Mylan did when facing unusual drug approval delays.
Regulatory bodies should implement stringent pre-approval inspections and an ‘application integrity policy’ to remove applications and halt pipelines of companies found to be falsifying data.
Understand that some corporate cultures may disproportionately punish minor infractions while overlooking or even rewarding severe ethical breaches that jeopardize public safety.
If you need to blow the whistle on corporate misconduct, consider using a pseudonym and a burner email account to protect your identity, especially when facing potential retaliation.
If your initial reports of serious issues are dismissed, persist in communicating the problem and escalate it to higher authorities, clearly articulating the crime and its urgency.
Understand that large regulatory agencies may have internal silos where different departments operate independently, potentially leading to a lack of coordinated action on critical issues.
Regulatory bodies should fully utilize their existing enforcement tools, such as the ‘application integrity policy,’ to suspend or revoke approvals for companies engaged in systemic fraud.
When attempting to obtain information from government agencies, be aware that Freedom of Information Act (FOIA) requests can be slow and often ineffective, necessitating alternative strategies like cultivating internal sources.
Be critical when regulatory bodies appear to withhold crucial investigative information from oversight committees, as this behavior might suggest political pressure or deeper systemic issues.
Recognize how cultural concepts, such as ‘Jugaad’ in India (achieving goals by any means necessary), can influence corporate behavior and potentially lead to disregard for regulations and ethical standards.
For effective inspections, particularly in overseas manufacturing plants, focus on auditing quality control laboratories and analyzing computer metadata to detect data manipulation and deletion, rather than relying solely on provided physical documents.
Follow Catherine Eban on Twitter (@CatherineEban), LinkedIn, and visit her website (CatherineEban.com) for ongoing information and insights on drug quality and related topics.