A Senate Committee has voted to require drug companies to justify steep drug price hikes to the federal government; Pfizer has added former FDA Commissioner Scott Gottlieb, MD, to its board of directors; the FDA warned consumers of potential cybersecurity risks associated with certain mini Medtronic insulin pumps.
The Senate Committee on Health, Education, Labor, and Pensions voted in favor of a measure that would require drug companies to justify drug price hikes if they exceed 10% in a year or 25% over 3 years. The bill also has bipartisan support in the House, reported STAT News. Representative Jan Schakowsky, D-Illinois, has introduced a similar bill under which drug companies would have to submit a report to HHS that includes the percentage of a planned drug price increase and a justification for the increase. The bill would also require drug companies to provide detailed information on the revenue and profits of the drug, the company’s marketing expenditures, and money spent on research and development.
Former FDA Commissioner Scott Gottlieb, MD, has joined Pfizer’s board of directors. Albert Bourla, who took over as chief executive officer in January, has led the shift to reorganize the company in the last year. In July, Pfizer announced plans to reorganize into 3 units, separating its consumer healthcare business that it had been trying to sell. During his time at the FDA, Gottlieb encouraged wider use of biosimilars, which could help Pfizer navigate the landscape. Pfizer, along with other companies, has expressed frustrations with barriers to widespread adoption of the drugs, according to CNBC. The FDA has issued a warning to patients and providers about potential cybersecurity risks associated with certain mini Medtronic insulin pumps. The MiniMed 508 insulin pump and MiniMed Paradigm series insulin pumps have been recalled because of the possible hacking risks. According to the FDA, there is concern that hackers could potentially connect wirelessly to the insulin pump and change the settings, which would allow the hacker to over deliver insulin to a patient or stop insulin delivery. To date, there are no confirmed reports of patient harm related to these potential hacking risks.